You cannot select more than 25 topics Topics must start with a letter or number, can include dashes ('-') and can be up to 35 characters long.
mercury-parser/fixtures/clinicaltrials.gov/1551708504719.html

1303 lines
80 KiB
HTML

<!DOCTYPE html>
<html xmlns="https://www.w3.org/1999/xhtml" lang='en'>
<head>
<meta http-equiv="X-UA-Compatible" content="IE=edge" />
<meta name="viewport" content="width=device-width, initial-scale=1">
<meta http-equiv="content-type" content="text/html; charset=UTF-8" />
<meta name="robots" content="noindex,nofollow"/>
<meta name="referrer" content="origin-when-cross-origin"/>
<title>Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer - Full Text View - ClinicalTrials.gov</title>
<link href="/ct2/show/NCT03746262" rel="canonical"/>
<!-- Open Graph data -->
<meta property="og:type" content="article" />
<meta property="og:title" content="Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer - Full Text View - ClinicalTrials.gov">
<meta property="og:image" content="https://clinicaltrials.gov/ct2/html/images/ct.gov-nlm-nih-logo.png">
<meta property="og:description" content="Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer - Full Text View.">
<meta property="og:url" content="https://clinicaltrials.gov/ct2/show/NCT03746262">
<link rel="shortcut icon" href="/ct2/html/images/favicon.ico" />
<link rel='apple-touch-icon-precomposed' href='/ct2/html/images/apple-touch-icon-144x144.png' sizes='144x144'>
<link rel='apple-touch-icon-precomposed' href='/ct2/html/images/apple-touch-icon-114x114.png' sizes='114x114'>
<link rel='apple-touch-icon-precomposed' href='/ct2/html/images/apple-touch-icon-72x72.png' sizes='72x72'>
<link rel='apple-touch-icon-precomposed' href='/ct2/html/images/apple-touch-icon-precomposed.png' >
<link rel='apple-touch-icon-precomposed' href='/ct2/html/images/apple-touch-icon.png' >
<link rel="stylesheet" type="text/css" href="/ct2/html/jquery/css/superfish.css?v=26" media="screen" />
<link rel="stylesheet" type="text/css" href="/ct2/html/css/glossary.css?v=26" />
<link rel="stylesheet" type="text/css" href="/ct2/html/css/base.css?v=26" />
<link rel="stylesheet" type="text/css" href="/ct2/html/css/print.css?v=26" media="print" />
<link rel="stylesheet" href="/ct2/html/css/w3-ct.css?v=26" type="text/css" />
<!--[if lt IE 9]>
<link rel="stylesheet" href="/ct2/html/css/w3-ct-oldIE.css?v=26" type="text/css" />
<![endif]-->
<script src="https://use.fontawesome.com/20a31629ec.js"></script>
<!--[if lte IE 7]>
<link href="/ct2/html/css/target-IE7-and-below.css" rel="stylesheet" type="text/css">
<![endif]-->
<style type="text/css">
h2
{
background-color: #EAEAEA;
}
</style>
<link href="/ct2/html/css/trial-record.css?v=26" rel="stylesheet" type="text/css" />
<script type="text/javascript" src="/ct2/html/jquery/js/jquery.min.js?v=26"></script><noscript></noscript>
<script type="text/javascript" src="/ct2/html/jquery/js/superclick.js?v=26"></script><noscript></noscript>
<script type="text/javascript" src="/ct2/html/jquery/js/jquery.cookie.js?v=26"></script><noscript></noscript>
<script type="text/javascript" src="/ct2/html/js/ct.js?v=26"></script><noscript></noscript>
<script type="text/javascript" src="/ct2/html/js/ctmenu.js?v=26"></script><noscript></noscript>
<script type="text/javascript" src="/ct2/html/images/foresee/foresee-trigger.js"></script><noscript></noscript>
<script type="text/javascript">
$(window).on('load', function(){
loadCTCommon();
});
</script><noscript></noscript>
<script>
var theURL = "/ct2/show/NCT03746262?term=Guardant+Health"+window.location.hash;
history.replaceState(null,null,theURL);
</script>
<script type="text/javascript">
ncbi_pingWithImage=true;
__ncbi_stat_url="//www.ncbi.nlm.nih.gov/stat";
</script>
<meta name="ncbi_sid" content="8618fae5c8f65986_11c68aSID"/>
<meta name="ncbi_app" content="ctgov"/>
<meta name="ncbi_db" content="ctgov"/>
<meta name="ncbi_pdid" content="show_study"/>
<meta name="ncbi_pcid" content="NCT03746262"/>
<meta name="ncbi_ctreqid" content="RRe07GaZ"/>
<meta name="ncbi_ctsessid" content="SRe05daS"/>
<meta name="ncbi_ctipid" content="IuTE5x7r"/>
<meta name="ncbi_cthost" content="wp2"/>
<meta name="ncbi_ctterm" content="Guardant Health"/>
</head>
<body class="js ct-one-column"> <div id="glossary" class="glossary"
aria-describedby="glossary-result" aria-hidden="true">
<button
title="Close glossary"
class="js-glossary-close button button--close js-glossary-toggle usa-button-unstyled"
><span class="usa-sr-only">Hide glossary</span>
<i class="fa fa-times" aria-hidden="true"></i>
</button>
<h4 class="glossary-heading">Glossary</h4>
<p>
Study record managers: refer to the <a href="https://clinicaltrials.gov/ct2/manage-recs/resources#DataElement"><u>Data Element Definitions</u></a> if submitting registration or results information.
</p>
<p>
<label for="glossary-search" class="label">Search for terms</label>
</p>
<span class="clearable-input">
<input id="glossary-search" class="js-glossary-search">
<span data-clear-input="" class="js-glossary-clear button js-glossary-toggle usa-button-unstyled">x</span>
</span>
<div class="glossary__content" id="glossary-result">
<ul class="js-glossary-list"></ul>
</div>
</div>
<div id="skip"> <a href="#main-content">Skip to Main Content</a> </div>
<div id="workingDim" class="ct-dim">
<div id="workingIndicator" class="ct-workingBox" style="text-align:center;vertical-align:middle;">
<img alt="Working..." src="/ct2/html/images/working.gif" height="48" >
</div>
</div>
<script type="text/javascript" src="/ct2/html/js/working.js"></script><noscript></noscript>
<div id="wrapper">
<div class="ct-inner_wrapper"> <a href="/ct2/home" style='float:left;border-bottom-width:0;min-width:200px;width:30%;'><img src='/ct2/html/images/ct.gov-nlm-nih-logo.png' alt='ClinicalTrials.gov'/></a>
<div id="hamburger" class="w3-hide-medium w3-hide-large" style="float:right;border-width:0;display:block;margin-left:1em;padding:4px;"
title="Show menus">
<img src="/ct2/html/images/hamburgerMenuIcon.png" alt="ClinicalTrials.gov Menu" style="max-width:30px;cursor:pointer;"
onclick="$('#global-nav-popupMenu').toggle();"/>
</div>
<div id="global-nav-popupMenu" class="w3-hide-medium w3-hide-large w3-modal w3-center"
style="display:none;" onclick="$('#global-nav-popupMenu').hide();"> <div id="global-nav-popupMenu-content" class="w3-modal-content">
<div class="w3-container">
<span onclick="$('#global-nav-popupMenu').hide();"
class="w3-closebtn">&times;</span>
<ul class="sf-menu sf-vertical">
<li class="first"><a href="/ct2/search/index">Find Studies<img src="/ct2/html/images/pulldown.png" alt="Find Studies Menu"></a>
<ul>
<li ><a href="/ct2/home">New Search</a></li>
<li ><a href="/ct2/search/advanced">Advanced Search</a></li>
<li ><a href="/ct2/search/browse?brwse=cond_cat">See Studies by Topic</a></li>
<li ><a href="/ct2/search/map">See Studies on Map</a></li>
<li class="new-group"><a href="/ct2/help/how-find/index">How to Search</a></li>
<li ><a href="/ct2/help/how-use-search-results">How to Use Search Results</a></li>
<li ><a href="/ct2/help/how-find/find-study-results">How to Find Results of Studies</a></li>
<li ><a href="/ct2/help/how-read-study">How to Read a Study Record</a></li>
</ul>
</li>
<li><a href="/ct2/about-studies">About Studies<img src="/ct2/html/images/pulldown.png" alt="About Studies Menu"></a>
<ul>
<li><a href="/ct2/about-studies/learn">Learn About Studies</a></li>
<li><a href="/ct2/about-studies/other-sites">Other Sites About Studies</a></li>
<li><a href="/ct2/about-studies/glossary">Glossary of Common Site Terms</a></li>
</ul>
</li>
<li><a href="/ct2/manage-recs">Submit Studies<img src="/ct2/html/images/pulldown.png" alt="Submit Studies Menu"></a>
<ul>
<li><a href="/ct2/manage-recs/background">Why Should I Register and Submit Results?</a></li>
<li><a href="/ct2/manage-recs/fdaaa">FDAAA 801 and the Final Rule</a></li>
<li class="new-group"><a href="/ct2/manage-recs/how-apply">How to Apply for an Account</a></li>
<li><a href="/ct2/manage-recs/how-register">How to Register Your Study</a></li>
<li><a href="/ct2/manage-recs/how-edit">How to Edit Your Study Record</a></li>
<li><a href="/ct2/manage-recs/how-report">How to Submit Your Results</a></li>
<li class="new-group"><a href="/ct2/manage-recs/faq">Frequently Asked Questions</a></li>
<li ><a href="/ct2/manage-recs/resources">Support Materials</a></li>
<li ><a href="/ct2/manage-recs/present">Training Materials</a></li>
</ul>
</li>
<li><a href="/ct2/resources">Resources<img src="/ct2/html/images/pulldown.png" alt="Resources Menu"></a>
<ul>
<li ><a href="/ct2/resources/pubs">Selected Publications</a></li>
<li ><a href="/ct2/resources/alert">Clinical Alerts and Advisories</a></li>
<li ><a href="/ct2/resources/rss">RSS Feeds</a></li>
<li class="new-group"><a href="/ct2/resources/trends">Trends, Charts, and Maps</a></li>
<li ><a href="/ct2/resources/download">Downloading Content for Analysis</a></li>
</ul>
</li>
<li class="last"><a href="/ct2/about-site">About Site<img src="/ct2/html/images/pulldown.png" alt="About Site Menu"></a>
<ul>
<li class="new-group"><a href="/ct2/about-site/new">What's New</a></li>
<li ><a href="/ct2/about-site/background">ClinicalTrials.gov Background</a></li>
<li ><a href="/ct2/about-site/results">About the Results Database</a></li>
<li ><a href="/ct2/about-site/history">History, Policies, and Laws</a></li>
<li ><a href="/ct2/about-site/for-media">Media/Press Resources</a></li>
<li class="new-group"><a href="/ct2/about-site/link-to">Linking to This Site</a></li>
<li ><a href="/ct2/about-site/terms-conditions">Terms and Conditions</a></li>
<li ><a href="/ct2/about-site/disclaimer">Disclaimer</a></li>
</ul>
</li>
</ul>
</div>
</div>
</div>
<div
style="float:right;margin-top:1.5%;"
class="w3-hide-small">
<ul class="sf-menu sf-vertical">
<li class="first"><a href="/ct2/search/index">Find Studies<img src="/ct2/html/images/pulldown.png" alt="Find Studies Menu"></a>
<ul>
<li ><a href="/ct2/home">New Search</a></li>
<li ><a href="/ct2/search/advanced">Advanced Search</a></li>
<li ><a href="/ct2/search/browse?brwse=cond_cat">See Studies by Topic</a></li>
<li ><a href="/ct2/search/map">See Studies on Map</a></li>
<li class="new-group"><a href="/ct2/help/how-find/index">How to Search</a></li>
<li ><a href="/ct2/help/how-use-search-results">How to Use Search Results</a></li>
<li ><a href="/ct2/help/how-find/find-study-results">How to Find Results of Studies</a></li>
<li ><a href="/ct2/help/how-read-study">How to Read a Study Record</a></li>
</ul>
</li>
<li><a href="/ct2/about-studies">About Studies<img src="/ct2/html/images/pulldown.png" alt="About Studies Menu"></a>
<ul>
<li><a href="/ct2/about-studies/learn">Learn About Studies</a></li>
<li><a href="/ct2/about-studies/other-sites">Other Sites About Studies</a></li>
<li><a href="/ct2/about-studies/glossary">Glossary of Common Site Terms</a></li>
</ul>
</li>
<li><a href="/ct2/manage-recs">Submit Studies<img src="/ct2/html/images/pulldown.png" alt="Submit Studies Menu"></a>
<ul>
<li><a href="/ct2/manage-recs/background">Why Should I Register and Submit Results?</a></li>
<li><a href="/ct2/manage-recs/fdaaa">FDAAA 801 and the Final Rule</a></li>
<li class="new-group"><a href="/ct2/manage-recs/how-apply">How to Apply for an Account</a></li>
<li><a href="/ct2/manage-recs/how-register">How to Register Your Study</a></li>
<li><a href="/ct2/manage-recs/how-edit">How to Edit Your Study Record</a></li>
<li><a href="/ct2/manage-recs/how-report">How to Submit Your Results</a></li>
<li class="new-group"><a href="/ct2/manage-recs/faq">Frequently Asked Questions</a></li>
<li ><a href="/ct2/manage-recs/resources">Support Materials</a></li>
<li ><a href="/ct2/manage-recs/present">Training Materials</a></li>
</ul>
</li>
<li><a href="/ct2/resources">Resources<img src="/ct2/html/images/pulldown.png" alt="Resources Menu"></a>
<ul>
<li ><a href="/ct2/resources/pubs">Selected Publications</a></li>
<li ><a href="/ct2/resources/alert">Clinical Alerts and Advisories</a></li>
<li ><a href="/ct2/resources/rss">RSS Feeds</a></li>
<li class="new-group"><a href="/ct2/resources/trends">Trends, Charts, and Maps</a></li>
<li ><a href="/ct2/resources/download">Downloading Content for Analysis</a></li>
</ul>
</li>
<li class="last"><a href="/ct2/about-site">About Site<img src="/ct2/html/images/pulldown.png" alt="About Site Menu"></a>
<ul>
<li class="new-group"><a href="/ct2/about-site/new">What's New</a></li>
<li ><a href="/ct2/about-site/background">ClinicalTrials.gov Background</a></li>
<li ><a href="/ct2/about-site/results">About the Results Database</a></li>
<li ><a href="/ct2/about-site/history">History, Policies, and Laws</a></li>
<li ><a href="/ct2/about-site/for-media">Media/Press Resources</a></li>
<li class="new-group"><a href="/ct2/about-site/link-to">Linking to This Site</a></li>
<li ><a href="/ct2/about-site/terms-conditions">Terms and Conditions</a></li>
<li ><a href="/ct2/about-site/disclaimer">Disclaimer</a></li>
</ul>
</li>
</ul>
<div style="clear:both;"></div>
</div>
<div style="clear:both;"></div>
</div>
<div class="ct-outer_breadcrumb w3-container">
<div id="breadcrumb">
<ul class="ct-horz-list w3-left">
<li><a href="/ct2/home">Home</a></li>
<li><a href="/ct2/results?term=Guardant+Health">Search Results</a></li>
<li>Study Record Detail</li>
</ul>
<div id="savedStudies" class="w3-right">
<div id="cart" style="cursor:pointer;" onclick="location.href=('/ct2/results'+cartToURL()); showWorking();">
<button class="ct-savedStudiesEnabled" id="open-cart-link" type="button"
onclick="location.href=('/ct2/results'+cartToURL()); showWorking();"
title="Show previously saved studies.">Saved Studies</button>
</div>
</div>
<script type="text/javascript" src="/ct2/html/js/cart.js?v=26"></script><noscript></noscript>
<script type="text/javascript">
$(document).ready(function(){
$("input#saved").prop( 'checked', (inCart("NCT03746262")>=0));
});
</script>
<div class="w3-right" style="margin-right: 1em;">
<label for="saved" title="Add or Remove this study in the Saved Studies list"><input type="checkbox" id="saved" name="NCT03746262" onchange="updateCart('NCT03746262');" style="margin-left:1em;"> Save this study </label>
</div>
<div id="maxSavedStudies-popup" class="w3-modal" style="cursor:pointer;border:2px groove" onclick="$('#maxSavedStudies-popup').hide();">
<div id="maxSavedStudies-popup-content" class="w3-modal-content">
<div class="w3-display-container" style="border:1px solid #ccc;background-color:#eee;">
<form>
<div class="w3-center" style="font-size:large;font-weight:bold;padding:3ex 1.5em;">
<img src="/ct2/html/images/warning.png" alt="Maximum Saved Studies Reached" style="max-width:1.0rem;cursor:pointer;"/>
<b>Warning</b>
<div style="margin-top:1ex;margin-bottom:0.5ex;">You have reached the maximum number of saved studies (100).</div>
<div>Please remove one or more studies before adding more.</div>
</div>
<div class="w3-center" style="padding-bottom:1.5ex">
<input class="ct-searchButton" type="button" style="opacity:1.0;font-weight:bold;font-size:inherit;padding:1.1ex 1em;" onclick="$('#maxSavedStudies-popup').hide();" value="Close" title="Close this dialog"/>
</div>
</form>
</div>
</div>
</div>
</div>
</div>
<div style="clear:both;"></div>
<div id="main-content"tabindex='-1'>
<div class="tr-indent2">
<h1 class="tr-h1 ct-sans-serif tr-solo_record">Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer</h1>
<div class="row">
<div class="tr-column tr-left">
<div class="usa-alert usa-alert-warning" style="clear:both;margin:2ex 2em;">
<table>
<tr>
<td style="width:5%">
<img src="/ct2/html/images/warning.png" style="width:1.3em;" alt=""/>
</td>
<td>
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our <a href="/ct2/about-site/disclaimer">disclaimer</a> for details.
</td>
</tr>
</table>
</div> </div>
<!--
<div style="float:right;margin-right:4em">ClinicalTrials.gov Identifier: NCT03746262</div>
-->
<div class="tr-column tr-right">
<table style="width:90%">
<tr><td>ClinicalTrials.gov Identifier: NCT03746262</td>
</tr>
<tr><td>
<div class="tr-status tr-not-recruiting-colors" >
<span style="display:inline;" class="term" data-term="Recruitment Status" title="Show definition">Recruitment Status <i class="fa fa-info-circle term" aria-hidden="true" data-term="Recruitment Status" style="border-bottom-style:none;"></i></span> :
Completed
<div style="font-size:inherit">
<span style="display:inline;" class="term" data-term="First Posted" title="Show definition">First Posted <i class="fa fa-info-circle term" aria-hidden="true" data-term="First Posted" style="border-bottom-style:none;"></i></span> : November 19, 2018</div>
<div style="font-size:inherit">
<span style="display:inline;" class="term" data-term="Last Update Posted" title="Show definition">Last Update Posted <i class="fa fa-info-circle term" aria-hidden="true" data-term="Last Update Posted" style="border-bottom-style:none;"></i></span> : November 21, 2018</div>
</div>
</td>
</tr>
</table>
</div>
</div>
<div class="tr-info-title">Sponsor:</div>
<div class="tr-info-text" id="sponsor"> Wake Forest University <span class="hit_inf">Health</span> Sciences </div>
<div class="tr-info-title">Collaborators:</div>
<div class="tr-info-text" id="sponsor1"><span class="hit_inf">Guardant Health</span>, Inc.</div>
<div class="tr-info-text" id="sponsor2">National Cancer Institute (NCI)</div>
<div class="tr-info-title">Information provided by (Responsible Party):</div>
<div class="tr-info-text" id="responsibleparty">Wake Forest University Health Sciences</div>
</div>
<br>
<div id="tabs">
<ul id="tab-links">
<li id="full-text" class="current">Study Details </li>
<li id="tabular" ><a href="/ct2/show/record/NCT03746262?term=Guardant+Health" >Tabular View</a></li>
<li id="results" ><a href="/ct2/show/results/NCT03746262?term=Guardant+Health">No Results Posted</a></li>
<li id="disclaimer"><a title="Disclaimer - opens new window" href="/ct2/about-site/disclaimer" onclick="openNewWindow('/ct2/about-site/disclaimer'); return false"
>Disclaimer</a></li>
<li id="howtoread"><a title="How to Read a Study Record - opens new window" href="/ct2/help/how-read-study" onclick="openNewWindow('/ct2/help/how-read-study'); return false"
>How to Read a Study Record</a></li>
</ul>
</div> <!--
<div style="background-color:#f6f6f6;margin-top:5.0ex;padding-bottom:1.5ex;"> </div>
-->
<div id="tab-body">
<div class="tr-indent2" style="background-color:white;">
<!-- purpose_section -->
<div class="tr-indent1" style="margin-top:1ex">
<div class="tr-subsection">
<div class="ct-header2"><a id="studydesc"></a>Study Description</div>
<div class="tr-underline"></div>
<div class="tr-dropdown" style="padding-right:10em">
Go&nbsp;to&nbsp;
<button class="tr-dropbtn" style="font-weight:bold; font-size:14px">
<img src="/ct2/html/images/pulldown.png" alt="sections">
</button>
<div class="tr-dropdown-content">
<a href="#wrapper">Top of Page</a>
<a href="#studydesc">Study Description</a>
<a href="#studydesign">Study Design</a>
<!-- arms and groups table -->
<a href="#armgroup">Groups and Cohorts</a>
<a href="#outcomemeasures">Outcome Measures</a>
<a href="#eligibility">Eligibility Criteria</a>
<a href="#contactlocation">Contacts and Locations</a>
<a href="#moreinfo">More Information</a>
</div>
</div>
</div>
<div class="tr-indent2" style="margin-top:2ex">
<div class="ct-body3">Brief Summary:</div>
<div class="ct-body3 tr-indent2">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment.</div><br/>
<!-- condition, intervention, phase summary table -->
<table class="ct-data_table tr-data_table" border="1" style="margin:auto;width:80%;">
<tr style="text-align:left;">
<th class="ct-header3 tr-pale_banner_color">
<span style="display:inline;" class="term" data-term="Condition/disease" title="Show definition">Condition or disease <i class="fa fa-info-circle term" aria-hidden="true" data-term="Condition/disease" style="border-bottom-style:none;"></i></span> </th>
</tr>
<tr style="text-align:left;vertical-align:top;">
<td class="ct-body3">
<span style="display:block;margin-bottom:1ex;">Non Small Cell Lung Cancer</span>
</td>
</tr>
</table>
<br/>
<a id="desc"></a>
<!-- detailed description -->
<div class="ct-body3"><a id="detaileddesc"></a>Detailed Description:</div>
<div class="ct-body3 tr-indent2">The purpose of this research study is to evaluate a blood test to measure circulating tumor DNA (ctDNA). It is hypothesized that ctDNA may identify patients who can be considered for additional therapy. 40 People with non-metastatic non-small cell lung cancer will be asked to take part in this study. Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times. These times will be before primary treatment (either surgery or radiation therapy), 1 month after primary treatment, and 4 months after primary treatment. The total amount of blood withdrawn during the study will be approximately 9 teaspoons. Participants will be followed every 3 months for 12 months to determine if a confirmed recurrence or progression has occurred. Participants will also be asked to complete questionnaires on their quality of life and their smoking behaviors. As part of this study, a blood sample will be obtained and DNA from participants blood sample will be purified. DNA, or deoxyribonucleic acid, stores and transmits inherited traits, such as eye color or blood type. As part of this research project, participant's DNA will be studied in an effort to find out if there are genes that contribute to medical conditions like their cancer that are part of the study. If participants have surgery to have tumor removed or if participants have a biopsy of their tumor, the study would like to take some of the leftover tissue to purify and study the DNA from the tissue sample.</div>
<br/>
</div>
<div class="tr-subsection">
<div class="ct-header2"><a id="studydesign"></a>Study Design</div>
<div class="tr-underline"></div>
<div class="tr-dropdown" style="padding-right:10em">
Go&nbsp;to&nbsp;
<button class="tr-dropbtn" style="font-weight:bold; font-size:14px">
<img src="/ct2/html/images/pulldown.png" alt="sections">
</button>
<div class="tr-dropdown-content">
<a href="#wrapper">Top of Page</a>
<a href="#studydesc">Study Description</a>
<a href="#studydesign">Study Design</a>
<!-- arms and groups table -->
<a href="#armgroup">Groups and Cohorts</a>
<a href="#outcomemeasures">Outcome Measures</a>
<a href="#eligibility">Eligibility Criteria</a>
<a href="#contactlocation">Contacts and Locations</a>
<a href="#moreinfo">More Information</a>
</div>
</div>
</div>
<p>
<table class="tr-layout_table" style="margin-bottom:2ex;">
<caption>Layout table for study information</caption>
<thead>
<tr>
<th id="studyInfoColTitle"></th>
<th id="studyInfoColData"></th>
</tr>
</thead>
<tr style="vertical-align:top;">
<td headers="studyInfoColTitle" style="text-align:right;white-space:nowrap;">
<span style="display:inline;" class="term" data-term="Study Type" title="Show definition">Study Type <i class="fa fa-info-circle term" aria-hidden="true" data-term="Study Type" style="border-bottom-style:none;"></i></span> :</td>
<td headers="studyInfoColData" style="padding-left:1em">
Observational
</td>
</tr>
<tr style="vertical-align:top;">
<td headers="studyInfoColTitle" style="text-align:right;white-space:nowrap;">Actual
<span style="display:inline;" class="term" data-term="Enrollment" title="Show definition">Enrollment <i class="fa fa-info-circle term" aria-hidden="true" data-term="Enrollment" style="border-bottom-style:none;"></i></span> :</td>
<td headers="studyInfoColData" style="padding-left:1em">40 participants</td>
</tr>
<tr style="vertical-align:top;">
<td headers="studyInfoColTitle" style="text-align:right;white-space:nowrap;">Observational Model:</td>
<td headers="studyInfoColData" style="padding-left:1em"> Cohort</td>
</tr>
<tr style="vertical-align:top;">
<td headers="studyInfoColTitle" style="text-align:right;white-space:nowrap;">Time Perspective:</td>
<td headers="studyInfoColData" style="padding-left:1em"> Prospective</td>
</tr>
<tr style="vertical-align:top;">
<!--
<td headers="studyInfoColTitle" style="padding-top:2ex;text-align:right;white-space:nowrap;">Official Title:</td>
-->
<td headers="studyInfoColTitle" style="text-align:right;white-space:nowrap;">Official Title:</td>
<td headers="studyInfoColData" style="padding-left:1em;">A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer</td>
</tr>
<tr style="vertical-align:top;">
<td headers="studyInfoColTitle" style="text-align:right;white-space:nowrap;"> Actual <span style="display:inline;" class="term" data-term="Study Start Date" title="Show definition">Study Start Date <i class="fa fa-info-circle term" aria-hidden="true" data-term="Study Start Date" style="border-bottom-style:none;"></i></span> :</td>
<td headers="studyInfoColData" style="padding-left:1em">May 13, 2016</td>
</tr>
<tr style="vertical-align:top;">
<td headers="studyInfoColTitle" style="text-align:right;white-space:nowrap;"> Actual <span style="display:inline;" class="term" data-term="Primary Completion Date" title="Show definition">Primary Completion Date <i class="fa fa-info-circle term" aria-hidden="true" data-term="Primary Completion Date" style="border-bottom-style:none;"></i></span> :</td>
<td headers="studyInfoColData" style="padding-left:1em">August 10, 2018</td>
</tr>
<tr style="vertical-align:top;">
<td headers="studyInfoColTitle" style="text-align:right;white-space:nowrap;"> Actual <span style="display:inline;" class="term" data-term="Study Completion Date" title="Show definition">Study Completion Date <i class="fa fa-info-circle term" aria-hidden="true" data-term="Study Completion Date" style="border-bottom-style:none;"></i></span> :</td>
<td headers="studyInfoColData" style="padding-left:1em">August 10, 2018</td>
</tr>
</table>
<!-- NLM links -->
<p>
<div class="tr-indent2" style="background: linear-gradient(#FFFFFF, #EEEEEE); width:60%">
<div class="usa-alert usa-alert-warning">
<strong>Resource links provided by the National Library of Medicine</strong>
<img src="/ct2/html/images/NIH_NLM_ABRV_BLK_4.png" style="width:5em; float:right;" alt=""/>
<p>
<p>
<!-- ghr links -->
<div style="margin-bottom:2ex">
<a class="tr-study-link" href="https://ghr.nlm.nih.gov/" title="Genetics Home Reference" onclick="openNewWindow('https://ghr.nlm.nih.gov/'); return false">Genetics Home Reference</a> related topics:
<a class="tr-study-link" style="margin-left:0.5em;" href="https://ghr.nlm.nih.gov/condition/lung-cancer" title="Lung&#160;cancer at Genetics Home Reference" onclick="openNewWindow('https://ghr.nlm.nih.gov/condition/lung-cancer'); return false">Lung&#160;cancer</a>
</div>
<!-- medline links -->
<div style="margin-bottom:2ex;">
<a class="tr-study-link" href="https://medlineplus.gov/" title="MedlinePlus" onclick="openNewWindow('https://medlineplus.gov/'); return false">MedlinePlus</a> related topics:
<a class="tr-study-link" style="margin-left:0.5em;" href="https://medlineplus.gov/lungcancer.html" title="Lung&#160;Cancer at MedlinePlus" onclick="openNewWindow('https://medlineplus.gov/lungcancer.html'); return false">Lung&#160;Cancer</a>
</div>
<!-- Ropr Link -->
<!-- Commented out RoPR
-->
<div style="margin-bottom:2ex;">
<a class="tr-study-link" href="/ct2/info/fdalinks" title="Show FDA resources page" onclick="openNewWindow('/ct2/info/fdalinks'); return false">U.S. FDA Resources</a>
</div>
</div>
</div>
<br/>
</div>
<!-- arms and groups table -->
<div class="tr-subsection">
<div class="ct-header2"><a id="armgroup"></a>Groups and Cohorts</div>
<div class="tr-underline"></div>
<div class="tr-dropdown" style="padding-right:10em">
Go&nbsp;to&nbsp;
<button class="tr-dropbtn" style="font-weight:bold; font-size:14px">
<img src="/ct2/html/images/pulldown.png" alt="sections">
</button>
<div class="tr-dropdown-content">
<a href="#wrapper">Top of Page</a>
<a href="#studydesc">Study Description</a>
<a href="#studydesign">Study Design</a>
<!-- arms and groups table -->
<a href="#armgroup">Groups and Cohorts</a>
<a href="#outcomemeasures">Outcome Measures</a>
<a href="#eligibility">Eligibility Criteria</a>
<a href="#contactlocation">Contacts and Locations</a>
<a href="#moreinfo">More Information</a>
</div>
</div>
</div>
<div style="padding-left:.8em; padding-right:1.2em;text-align:left;">
<p>
<table class="ct-data_table tr-data_table" style="padding:5px;width:100%;border-width:1px;">
<tr style="text-align:left;">
<th class="ct-header3 tr-pale_banner_color">
<span style="display:inline;" class="term" data-term="Group/Cohort" title="Show definition">Group/Cohort <i class="fa fa-info-circle term" aria-hidden="true" data-term="Group/Cohort" style="border-bottom-style:none;"></i></span> </th>
</tr>
<tr style="text-align:left;vertical-align:top;">
<td class="ct-body3">
Patients - Stage I treated with surgery
<div class="tr-indent2" style="margin-top:0.5ex">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations, and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>
</td>
</tr>
<tr style="text-align:left;vertical-align:top;">
<td class="ct-body3">
Patients - Stage I treated with radiotherapy
<div class="tr-indent2" style="margin-top:0.5ex">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>
</td>
</tr>
<tr style="text-align:left;vertical-align:top;">
<td class="ct-body3">
Patients - Stage II treated with surgery &amp; chemotherapy
<div class="tr-indent2" style="margin-top:0.5ex">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>
</td>
</tr>
<tr style="text-align:left;vertical-align:top;">
<td class="ct-body3">
Patients - Stage III treated with chemoradiotherapy
<div class="tr-indent2" style="margin-top:0.5ex">ctDNA measures will be taken and descriptive statistics will be estimated. These include means, standard deviations and 95% confidence intervals. Next, within group changes in ctDNA levels will be measured for each of the four groups. These change values will be estimated with 95% confidence intervals. In addition, paired t-tests will be performed to determine whether there were statistically significant changes in ctDNA levels at time points post-treatment or follow-up. After these paired analyses are performed, an exploratory longitudinal mixed model will be fit to examine the change in ctDNA levels.</div>
</td>
</tr>
</table>
</div>
<br/>
<!-- more details -->
<br/>
<div class="tr-subsection">
<div class="ct-header2"><a id="outcomemeasures"></a>Outcome Measures</div>
<div class="tr-underline"></div>
<div class="tr-dropdown" style="padding-right:10em">
Go&nbsp;to&nbsp;
<button class="tr-dropbtn" style="font-weight:bold; font-size:14px">
<img src="/ct2/html/images/pulldown.png" alt="sections">
</button>
<div class="tr-dropdown-content">
<a href="#wrapper">Top of Page</a>
<a href="#studydesc">Study Description</a>
<a href="#studydesign">Study Design</a>
<!-- arms and groups table -->
<a href="#armgroup">Groups and Cohorts</a>
<a href="#outcomemeasures">Outcome Measures</a>
<a href="#eligibility">Eligibility Criteria</a>
<a href="#contactlocation">Contacts and Locations</a>
<a href="#moreinfo">More Information</a>
</div>
</div>
</div>
<br/>
<div class="tr-indent3" style="margin-right:1em;">
<!-- primary outcomes -->
<div class="ct-body3">
<span style="display:inline;" class="term" data-term="Primary Outcome Measure" title="Show definition">Primary Outcome Measures <i class="fa fa-info-circle term" aria-hidden="true" data-term="Primary Outcome Measure" style="border-bottom-style:none;"></i></span> :
<ol style="margin-top:1ex; margin-bottom:1ex;">
<li style="margin-top:0.7ex;">Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC [&nbsp;Time&nbsp;Frame:&nbsp;up to 12 months&nbsp;]<div class="tr-indent2" style="margin-top:1ex;">ctDNA levels in patients with Stage I or II NSCLC treated with surgery compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment, and Follow-up.</div><br/>
<li style="margin-top:0.7ex;">Change in ctDNA levels in patients with Stage III NSCLC [&nbsp;Time&nbsp;Frame:&nbsp;up to 12 months&nbsp;]<div class="tr-indent2" style="margin-top:1ex;">ctDNA levels in patients with Stage III NSCLC treated with chemoradiotherapy compared with ctDNA levels in the rest of the cohort. Comparisons will be made at the following time points: Pre-treatment, Post-treatment , and Follow-up.</div><br/>
<li style="margin-top:0.7ex;">Change in ctDNA by treatment group [&nbsp;Time&nbsp;Frame:&nbsp;up to 12 months&nbsp;]<div class="tr-indent2" style="margin-top:1ex;">To determine the change in ctDNA by treatment group at the following time points: change from Pre-treatment to Post-treatment, and change from Pre-treatment to Follow-up.</div><br/>
</ol>
</div>
<br/>
<!-- secondary outcomes -->
<div class="ct-body3" style="margin-right:1em;">
<span style="display:inline;" class="term" data-term="Secondary Outcome Measure" title="Show definition">Secondary Outcome Measures <i class="fa fa-info-circle term" aria-hidden="true" data-term="Secondary Outcome Measure" style="border-bottom-style:none;"></i></span> :
<ol style="margin-top:1ex; margin-bottom:1ex;">
<li style="margin-top:0.7ex;"><span class="hit_inf">Health</span> Related Quality of Life- (HRQL) [&nbsp;Time&nbsp;Frame:&nbsp;up to 12 months&nbsp;]<div class="tr-indent2" style="margin-top:1ex;">A two part questionnaire, will be used to assess HRQL: (1) QLQ-C30, a core questionnaire covering general aspects of HRQL, and (2) QLQ-LC13, a lung cancer specific questionnaire. For the QLQ-C30 - All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. For the QLQ-LC13 - All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.</div><br/>
<li style="margin-top:0.7ex;">Number of Packs Smoked Per Day [&nbsp;Time&nbsp;Frame:&nbsp;up to 12 months&nbsp;]<div class="tr-indent2" style="margin-top:1ex;">The number of packs of tobacco participants smoked per day will be assessed and recorded</div><br/>
<li style="margin-top:0.7ex;">Number of Years Smoked [&nbsp;Time&nbsp;Frame:&nbsp;up to 12 months&nbsp;]<div class="tr-indent2" style="margin-top:1ex;">The number of years participants smoked will be recorded.</div><br/>
<li style="margin-top:0.7ex;">Number of Participants that have a Smoking Status [&nbsp;Time&nbsp;Frame:&nbsp;up to 12 months&nbsp;]<div class="tr-indent2" style="margin-top:1ex;">Participants will be asked about their current smoking status (yes/no). These answers will be recorded.</div><br/>
</ol>
</div>
<br/>
<span class="ct-body3">Biospecimen Retention: &nbsp; Samples With DNA</span><br/>
<div class="ct-body3 tr-indent3">
whole blood and tissue when available
</div>
<br/>
</div>
<!-- eligibility_section -->
<div class="tr-indent1" style="margin-top:3ex; border:1px solid white">
<div class="tr-subsection">
<div class="ct-header2"><a id="eligibility"></a>Eligibility Criteria</div>
<div class="tr-underline"></div>
<div class="tr-dropdown" style="padding-right:10em">
Go&nbsp;to&nbsp;
<button class="tr-dropbtn" style="font-weight:bold; font-size:14px">
<img src="/ct2/html/images/pulldown.png" alt="sections">
</button>
<div class="tr-dropdown-content">
<a href="#wrapper">Top of Page</a>
<a href="#studydesc">Study Description</a>
<a href="#studydesign">Study Design</a>
<!-- arms and groups table -->
<a href="#armgroup">Groups and Cohorts</a>
<a href="#outcomemeasures">Outcome Measures</a>
<a href="#eligibility">Eligibility Criteria</a>
<a href="#contactlocation">Contacts and Locations</a>
<a href="#moreinfo">More Information</a>
</div>
</div>
</div>
<br/>
<p>
<div class="tr-indent2" style="background: linear-gradient(#FFFFFF, #EEEEEE); width:80%">
<div class="usa-alert usa-alert-warning">
<strong>Information from the National Library of Medicine</strong>
<img src="/ct2/html/images/NIH_NLM_ABRV_BLK_4.png" style="width:5em; float:right;" alt=""/>
<p>
<p>
<em>Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, <a href="/ct2/about-studies/learn" title="Learn About Clinical Studies"><u>Learn About Clinical Studies.</u></a>
</em>
</div>
</div>
<br/>
<div class="tr-indent2">
<table class="tr-layout_table">
<caption>Layout table for eligibility information</caption>
<thead>
<tr>
<th id="elgType"></th>
<th id="elgData"></th>
</tr>
</thead>
<tr>
<td headers="elgType" style="text-align:right;white-space:nowrap;">Ages Eligible for Study: &nbsp; </td>
<td headers="elgData" style="padding-left:1em">18 Years and older &nbsp; (Adult, Older Adult)</td>
</tr>
<tr>
<td headers="elgType" style="text-align:right;white-space:nowrap;">Sexes Eligible for Study: &nbsp; </td>
<td headers="elgData" style="padding-left:1em">All</td>
</tr>
<tr>
<td headers="elgType" style="text-align:right;white-space:nowrap;">Accepts Healthy Volunteers: &nbsp; </td>
<td headers="elgData" style="padding-left:1em">No</td>
</tr>
<tr>
<td headers="elgType" style="text-align:right;white-space:nowrap;">Sampling Method: &nbsp; </td>
<td headers="elgData" style="padding-left:1em">Non-Probability Sample</td>
</tr>
</table>
<div class="ct-header3" style="margin-top:2ex">Study Population</div>
<div class="tr-indent2">Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.</div>
<div class="ct-header3" style="margin-top:2ex">Criteria</div>
<div class="tr-indent2"><p style="margin-top:1ex; margin-bottom:1ex;">Inclusion Criteria:</p>
<ul style="margin-top:1ex; margin-bottom:1ex;">
<li style="margin-top:0.7ex;">Patients with histologically confirmed or clinically suspected stage I, II or III NSCLC, provided such patients will be scheduled for a procedure that will provide histologic confirmation of the diagnosis (if the procedure does not provide histologic confirmation of the diagnosis of NSCLC the particular patient will be removed from the study and replaced).</li>
<li style="margin-top:0.7ex;">Scheduled for treatment with surgery or radiotherapy (Stage I), surgery and chemotherapy (Stage II), or chemoradiotherapy (Stage III). For stage I receiving radiotherapy, treatment must be stereotactic body radiation therapy (SBRT) consisting of 3-5 fractions.</li>
<li style="margin-top:0.7ex;">Ability to provide blood sample at the following time points: pre-treatment, 1 month post definitive treatment, and 4 post definitive treatment.</li>
<li style="margin-top:0.7ex;">Ability to understand and the willingness to sign an IRB-approved informed consent document.</li>
<li style="margin-top:0.7ex;">Staging studies including PET-CT for all patients prior to the initiation of primary treatment, as a pretreatment requirement. For patients with Stage II and III, MRI or CT of the brain is needed prior to the initiation of primary treatment. Patients, however, may be registered and have the pretreatment blood sample collected, provided that the staging studies are being scheduled. Registered patients who are found, after screening tests, to have Stage IV disease will be removed from the study and replaced.</li>
</ul>
<p style="margin-top:0ex; margin-bottom:1ex;">Exclusion Criteria:</p>
<ul style="margin-top:1ex; margin-bottom:1ex;">
<li style="margin-top:0.7ex;">Females who are pregnant</li>
<li style="margin-top:0.7ex;">History of organ transplant.</li>
<li style="margin-top:0.7ex;">For stage II and III patients, must be able to receive chemotherapy.</li>
<li style="margin-top:0.7ex;">Active cardiovascular issues in the past 6 months.</li>
</ul></div>
</div>
</div>
<!-- location_section -->
<a id="contacts"></a>
<div class="tr-indent1" style="margin-top:3ex">
<div class="tr-subsection">
<div class="ct-header2"><a id="contactlocation"></a>Contacts and Locations</div>
<div class="tr-underline"></div>
<div class="tr-dropdown" style="padding-right:10em">
Go&nbsp;to&nbsp;
<button class="tr-dropbtn" style="font-weight:bold; font-size:14px">
<img src="/ct2/html/images/pulldown.png" alt="sections">
</button>
<div class="tr-dropdown-content">
<a href="#wrapper">Top of Page</a>
<a href="#studydesc">Study Description</a>
<a href="#studydesign">Study Design</a>
<!-- arms and groups table -->
<a href="#armgroup">Groups and Cohorts</a>
<a href="#outcomemeasures">Outcome Measures</a>
<a href="#eligibility">Eligibility Criteria</a>
<a href="#contactlocation">Contacts and Locations</a>
<a href="#moreinfo">More Information</a>
</div>
</div>
</div>
<br/>
<div class="tr-indent2" style="margin-top:2ex">
<!--
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see <a href="/ct2/about-studies/learn" target="def_win" onClick="openNewWindow('/ct2/about-studies/learn'); return false;" title="Learn About Clinical Studies - opens new window"><u>Learn About Clinical Studies.</u></a>
<br/>
-->
<div style="background: linear-gradient(#FFFFFF, #EEEEEE); width:80%">
<div class="usa-alert usa-alert-warning">
<strong>Information from the National Library of Medicine</strong>
<img src="/ct2/html/images/NIH_NLM_ABRV_BLK_4.png" style="width:5em; float:right;" alt=""/>
<p>
<p>
<em>
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
</em>
<p>
<em>
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): <strong>NCT03746262</strong>
</em>
</div>
</div>
<br/>
<!-- contacts -->
<!-- locations -->
<a id="locn"></a>
<div class="ct-header3" style="margin-top:2ex">Locations</div>
<div class="tr-table_cover">
<table class="tr-layout_table tr-indent2">
<caption>Layout table for location information</caption>
<thead>
<tr>
<th id="locName"></th>
<th id="locStatus"></th>
</tr>
</thead>
<tr><td colspan="2" class="ct-header3" style="padding-top:2ex;white-space:nowrap;">United States, North Carolina</td></tr>
<tr>
<td headers="locName" style="padding:1ex 1em 0px 2em;white-space:nowrap;">Wake Forest Baptist Medical Center</td>
<td headers="locStatus"></td>
</tr>
<tr><td colspan="2" style="padding-left:4em;white-space:nowrap;">Winston-Salem, North Carolina, United States, 27157 </td></tr>
</table>
</div>
<!-- sponsors -->
<div class="ct-header3" style="margin-top:2ex">Sponsors and Collaborators</div>
<div class="tr-indent2" style="margin-top:1ex">Wake Forest University <span class="hit_inf">Health</span> Sciences</div>
<div class="tr-indent2" style="margin-top:1ex"><span class="hit_inf">Guardant Health</span>, Inc.</div>
<div class="tr-indent2" style="margin-top:1ex">National Cancer Institute (NCI)</div>
<!-- overall officials -->
<div class="ct-header3" style="margin-top:2ex">Investigators</div>
<div class="tr-table_cover">
<table class="tr-layout_table tr-indent2">
<caption>Layout table for investigator information</caption>
<thead>
<tr>
<th id="role" style="visibility:hidden"></th>
<th id="name" style="visibility:hidden"></th>
<th id="affiliation" style="visibility:hidden"></th>
<th id="address" style="visibility:hidden"></th>
</tr>
</thead>
<tr>
<td headers="role" style="padding:1ex 1em 0px 0px;white-space:nowrap;">Principal Investigator:</td>
<td headers="name" style="padding:1ex 1em 0px 0px;white-space:nowrap;">Stefan Grant, MD</td>
<td headers="affiliation" style="padding:1ex 1em 0px 0px;white-space:nowrap;">Wake Forest University <span class="hit_inf">Health</span> Sciences</td>
<td headers="address"></td>
</tr>
</table>
</div>
</div>
</div>
<!-- more_info_section -->
<!-- Large docs section -->
<!-- More info section -->
<div class="tr-indent1" style="margin-top:3ex; border:1px solid white">
<div class="tr-subsection">
<div class="ct-header2"><a id="moreinfo"></a>More Information</div>
<div class="tr-underline"></div>
<div class="tr-dropdown" style="padding-right:10em">
Go&nbsp;to&nbsp;
<button class="tr-dropbtn" style="font-weight:bold; font-size:14px">
<img src="/ct2/html/images/pulldown.png" alt="sections">
</button>
<div class="tr-dropdown-content">
<a href="#wrapper">Top of Page</a>
<a href="#studydesc">Study Description</a>
<a href="#studydesign">Study Design</a>
<!-- arms and groups table -->
<a href="#armgroup">Groups and Cohorts</a>
<a href="#outcomemeasures">Outcome Measures</a>
<a href="#eligibility">Eligibility Criteria</a>
<a href="#contactlocation">Contacts and Locations</a>
<a href="#moreinfo">More Information</a>
</div>
</div>
</div>
<div class="tr-indent2">
<br/>
<!-- Additional Information -->
<!-- Available Study Data/Document -->
<!-- References -->
<span class="ct-header3"> Publications:</span>
<div class="tr-indent2">
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtLR48Lg4BA6h9Ei4L3BUgWwNG0it." title="Anker P, Mulcahy H, Chen XQ, Stroun M. Detection of circulating tumour DNA in the blood (plasma/serum) of cancer patients. Cancer Metastasis Rev. 1999;18(1):65-73. Review." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtLR48Lg4BA6h9Ei4L3BUgWwNG0it.'); return false">Anker P, Mulcahy H, Chen XQ, Stroun M. Detection of circulating tumour DNA in the blood (plasma/serum) of cancer patients. Cancer Metastasis Rev. 1999;18(1):65-73. Review.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZK4jaK4ROK495d-3Ws8Gpw-PSB7gW." title="Sorenson GD, Pribish DM, Valone FH, Memoli VA, Bzik DJ, Yao SL. Soluble normal and mutated DNA sequences from single-copy genes in human blood. Cancer Epidemiol Biomarkers Prev. 1994 Jan-Feb;3(1):67-71." onclick="openNewWindow('/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZK4jaK4ROK495d-3Ws8Gpw-PSB7gW.'); return false">Sorenson GD, Pribish DM, Valone FH, Memoli VA, Bzik DJ, Yao SL. Soluble normal and mutated DNA sequences from single-copy genes in human blood. Cancer Epidemiol Biomarkers Prev. 1994 Jan-Feb;3(1):67-71.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZgFJOKCVOgC95d-3Ws8Gpw-PSB7gW." title="Minamoto T, Yamashita N, Ochiai A, Mai M, Sugimura T, Ronai Z, Esumi H. Mutant K-ras in apparently normal mucosa of colorectal cancer patients. Its potential as a biomarker of colorectal tumorigenesis. Cancer. 1995 Mar 15;75(6 Suppl):1520-6." onclick="openNewWindow('/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZgFJOKCVOgC95d-3Ws8Gpw-PSB7gW.'); return false">Minamoto T, Yamashita N, Ochiai A, Mai M, Sugimura T, Ronai Z, Esumi H. Mutant K-ras in apparently normal mucosa of colorectal cancer patients. Its potential as a biomarker of colorectal tumorigenesis. Cancer. 1995 Mar 15;75(6 Suppl):1520-6.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtOgFREg0jA6h9Ei4L3BUgWwNG0it." title="Sorenson GD. Detection of mutated KRAS2 sequences as tumor markers in plasma/serum of patients with gastrointestinal cancer. Clin Cancer Res. 2000 Jun;6(6):2129-37. Review." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtOgFREg0jA6h9Ei4L3BUgWwNG0it.'); return false">Sorenson GD. Detection of mutated KRAS2 sequences as tumor markers in plasma/serum of patients with gastrointestinal cancer. Clin Cancer Res. 2000 Jun;6(6):2129-37. Review.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtORCJLK4JA6h9Ei4L3BUgWwNG0it." title="Sorenson GD. A review of studies on the detection of mutated KRAS2 sequences as tumor markers in plasma/serum of patients with gastrointestinal cancer. Ann N Y Acad Sci. 2000 Apr;906:13-6. Review." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtORCJLK4JA6h9Ei4L3BUgWwNG0it.'); return false">Sorenson GD. A review of studies on the detection of mutated KRAS2 sequences as tumor markers in plasma/serum of patients with gastrointestinal cancer. Ann N Y Acad Sci. 2000 Apr;906:13-6. Review.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtcRF5LRCwA6h9Ei4L3BUgWwNG0it." title="Kirk GD, Camus-Randon AM, Mendy M, Goedert JJ, Merle P, Tr&#233;po C, Br&#233;chot C, Hainaut P, Montesano R. Ser-249 p53 mutations in plasma DNA of patients with hepatocellular carcinoma from The Gambia. J Natl Cancer Inst. 2000 Jan 19;92(2):148-53." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtcRF5LRCwA6h9Ei4L3BUgWwNG0it.'); return false">Kirk GD, Camus-Randon AM, Mendy M, Goedert JJ, Merle P, Tr&#233;po C, Br&#233;chot C, Hainaut P, Montesano R. Ser-249 p53 mutations in plasma DNA of patients with hepatocellular carcinoma from The Gambia. J Natl Cancer Inst. 2000 Jan 19;92(2):148-53.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjaKCBaK4nA6h9Ei4L3BUgWwNG0it." title="Jackson PE, Qian GS, Friesen MD, Zhu YR, Lu P, Wang JB, Wu Y, Kensler TW, Vogelstein B, Groopman JD. Specific p53 mutations detected in plasma and tumors of hepatocellular carcinoma patients by electrospray ionization mass spectrometry. Cancer Res. 2001 Jan 1;61(1):33-5." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjaKCBaK4nA6h9Ei4L3BUgWwNG0it.'); return false">Jackson PE, Qian GS, Friesen MD, Zhu YR, Lu P, Wang JB, Wu Y, Kensler TW, Vogelstein B, Groopman JD. Specific p53 mutations detected in plasma and tumors of hepatocellular carcinoma patients by electrospray ionization mass spectrometry. Cancer Res. 2001 Jan 1;61(1):33-5.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjWK45-KC8A6h9Ei4L3BUgWwNG0it." title="Shao ZM, Wu J, Shen ZZ, Nguyen M. p53 mutation in plasma DNA and its prognostic value in breast cancer patients. Clin Cancer Res. 2001 Aug;7(8):2222-7. Retraction in: Shao ZM, Wu J, Shen ZZ, Nguyen M. Clin Cancer Res. 2002 Sep;8(9):3027." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjWK45-KC8A6h9Ei4L3BUgWwNG0it.'); return false">Shao ZM, Wu J, Shen ZZ, Nguyen M. p53 mutation in plasma DNA and its prognostic value in breast cancer patients. Clin Cancer Res. 2001 Aug;7(8):2222-7. Retraction in: Shao ZM, Wu J, Shen ZZ, Nguyen M. Clin Cancer Res. 2002 Sep;8(9):3027.</a>
<div style="margin-top:1ex">
<span style="font-weight:bold; margin:0 1em 0 2em;">Retraction in:</span>
<a class="tr-study-link" href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCnSRFjLgCtA6h9Ei4L3BUgWwNG0it." title="Shao ZM, Wu J, Shen ZZ, Nguyen M. Clin Cancer Res. 2002 Sep;8(9):3027" onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCnSRFjLgCtA6h9Ei4L3BUgWwNG0it.'); return false">Shao ZM, Wu J, Shen ZZ, Nguyen M. Clin Cancer Res. 2002 Sep;8(9):3027</a>
</div>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZKCJOgC5Og495d-3Ws8Gpw-PSB7gW." title="Silva JM, Gonzalez R, Dominguez G, Garcia JM, Espa&#241;a P, Bonilla F. TP53 gene mutations in plasma DNA of cancer patients. Genes Chromosomes Cancer. 1999 Feb;24(2):160-1." onclick="openNewWindow('/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZKCJOgC5Og495d-3Ws8Gpw-PSB7gW.'); return false">Silva JM, Gonzalez R, Dominguez G, Garcia JM, Espa&#241;a P, Bonilla F. TP53 gene mutations in plasma DNA of cancer patients. Genes Chromosomes Cancer. 1999 Feb;24(2):160-1.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZKCJSK4JSRC95d-3Ws8Gpw-PSB7gW." title="Mayall F, Jacobson G, Wilkins R, Chang B. Mutations of p53 gene can be detected in the plasma of patients with large bowel carcinoma. J Clin Pathol. 1998 Aug;51(8):611-3." onclick="openNewWindow('/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZKCJSK4JSRC95d-3Ws8Gpw-PSB7gW.'); return false">Mayall F, Jacobson G, Wilkins R, Chang B. Mutations of p53 gene can be detected in the plasma of patients with large bowel carcinoma. J Clin Pathol. 1998 Aug;51(8):611-3.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtORCJcR4tA6h9Ei4L3BUgWwNG0it." title="Bruhn N, Beinert T, Oehm C, Jandrig B, Petersen I, Chen XQ, Possinger K, Fleischhacker M. Detection of microsatellite alterations in the DNA isolated from tumor cells and from plasma DNA of patients with lung cancer. Ann N Y Acad Sci. 2000 Apr;906:72-82." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCtORCJcR4tA6h9Ei4L3BUgWwNG0it.'); return false">Bruhn N, Beinert T, Oehm C, Jandrig B, Petersen I, Chen XQ, Possinger K, Fleischhacker M. Detection of microsatellite alterations in the DNA isolated from tumor cells and from plasma DNA of patients with lung cancer. Ann N Y Acad Sci. 2000 Apr;906:72-82.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZK4wOR0VcRF95d-3Ws8Gpw-PSB7gW." title="Chen XQ, Stroun M, Magnenat JL, Nicod LP, Kurt AM, Lyautey J, Lederrey C, Anker P. Microsatellite alterations in plasma DNA of small cell lung cancer patients. Nat Med. 1996 Sep;2(9):1033-5." onclick="openNewWindow('/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZK4wOR0VcRF95d-3Ws8Gpw-PSB7gW.'); return false">Chen XQ, Stroun M, Magnenat JL, Nicod LP, Kurt AM, Lyautey J, Lederrey C, Anker P. Microsatellite alterations in plasma DNA of small cell lung cancer patients. Nat Med. 1996 Sep;2(9):1033-5.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjEg0jcR4nA6h9Ei4L3BUgWwNG0it." title="Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, Espa&#241;a P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjEg0jcR4nA6h9Ei4L3BUgWwNG0it.'); return false">Gonzalez R, Silva JM, Sanchez A, Dominguez G, Garcia JM, Chen XQ, Stroun M, Provencio M, Espa&#241;a P, Anker P, Bonilla F. Microsatellite alterations and TP53 mutations in plasma DNA of small-cell lung cancer patients: follow-up study and prognostic significance. Ann Oncol. 2000 Sep;11(9):1097-104.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZK4wOR0Vcg495d-3Ws8Gpw-PSB7gW." title="Nawroz H, Koch W, Anker P, Stroun M, Sidransky D. Microsatellite alterations in serum DNA of head and neck cancer patients. Nat Med. 1996 Sep;2(9):1035-7." onclick="openNewWindow('/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZK4wOR0Vcg495d-3Ws8Gpw-PSB7gW.'); return false">Nawroz H, Koch W, Anker P, Stroun M, Sidransky D. Microsatellite alterations in serum DNA of head and neck cancer patients. Nat Med. 1996 Sep;2(9):1035-7.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCj-R4JWK4nA6h9Ei4L3BUgWwNG0it." title="Taback B, Giuliano AE, Hansen NM, Hoon DS. Microsatellite alterations detected in the serum of early stage breast cancer patients. Ann N Y Acad Sci. 2001 Sep;945:22-30." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCj-R4JWK4nA6h9Ei4L3BUgWwNG0it.'); return false">Taback B, Giuliano AE, Hansen NM, Hoon DS. Microsatellite alterations detected in the serum of early stage breast cancer patients. Ann N Y Acad Sci. 2001 Sep;945:22-30.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCV-RFV-R4BA6h9Ei4L3BUgWwNG0it." title="Taback B, O'Day SJ, Boasberg PD, Shu S, Fournier P, Elashoff R, Wang HJ, Hoon DS. Circulating DNA microsatellites: molecular determinants of response to biochemotherapy in patients with metastatic melanoma. J Natl Cancer Inst. 2004 Jan 21;96(2):152-6." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCV-RFV-R4BA6h9Ei4L3BUgWwNG0it.'); return false">Taback B, O'Day SJ, Boasberg PD, Shu S, Fournier P, Elashoff R, Wang HJ, Hoon DS. Circulating DNA microsatellites: molecular determinants of response to biochemotherapy in patients with metastatic melanoma. J Natl Cancer Inst. 2004 Jan 21;96(2):152-6.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjWgF5SR4BA6h9Ei4L3BUgWwNG0it." title="Taback B, Fujiwara Y, Wang HJ, Foshag LJ, Morton DL, Hoon DS. Prognostic significance of circulating microsatellite markers in the plasma of melanoma patients. Cancer Res. 2001 Aug 1;61(15):5723-6." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCjWgF5SR4BA6h9Ei4L3BUgWwNG0it.'); return false">Taback B, Fujiwara Y, Wang HJ, Foshag LJ, Morton DL, Hoon DS. Prognostic significance of circulating microsatellite markers in the plasma of melanoma patients. Cancer Res. 2001 Aug 1;61(15):5723-6.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZKCwOK4BSKC95d-3Ws8Gpw-PSB7gW." title="Goessl C, Heicappell R, M&#252;nker R, Anker P, Stroun M, Krause H, M&#252;ller M, Miller K. Microsatellite analysis of plasma DNA from patients with clear cell renal carcinoma. Cancer Res. 1998 Oct 15;58(20):4728-32." onclick="openNewWindow('/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZKCwOK4BSKC95d-3Ws8Gpw-PSB7gW.'); return false">Goessl C, Heicappell R, M&#252;nker R, Anker P, Stroun M, Krause H, M&#252;ller M, Miller K. Microsatellite analysis of plasma DNA from patients with clear cell renal carcinoma. Cancer Res. 1998 Oct 15;58(20):4728-32.</a>
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCnOgFwFK4VA6h9Ei4L3BUgWwNG0it." title="M&#252;ller HM, Widschwendter M. Methylated DNA as a possible screening marker for neoplastic disease in several body fluids. Expert Rev Mol Diagn. 2003 Jul;3(4):443-58. Review." onclick="openNewWindow('/ct2/bye/rQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRCnOgFwFK4VA6h9Ei4L3BUgWwNG0it.'); return false">M&#252;ller HM, Widschwendter M. Methylated DNA as a possible screening marker for neoplastic disease in several body fluids. Expert Rev Mol Diagn. 2003 Jul;3(4):443-58. Review.</a>
</div>
<div style="margin-top:2ex">
Collisson E, Mortimer S, Sebisanovic D, et al. Biopsy-free comprehensive tumor profiling of 1,000+ consecutive cancer patients using CLIA-certified commercial test and its clinical utility. Paper presented at: 2015 AACR Annual Meeting. Abstract #2403. 2015.
</div>
<div style="margin-top:2ex">
Talasaz A, Mortimer S, Sebisanovic D, et al. Use of the GUARDANT360 noninvasive tumor sequencing assay on 300 patients across colorectal, melanoma, lung, breast, and prostate cancers and its clinical utility. J Clin Oncol 32, 2014 (suppl; abstr e22041).
</div>
<div style="margin-top:2ex">
Austin LK, Avery T, Jaslow R, et al. Concordance of circulating tumor DNA (ctDNA) and next-generation sequencing (NGS) as molecular monitoring tools in metastatic breast cancer (MBC). Paper presented at: 2015 AACR Annual Meeting. Abstract #4918. 2015.
</div>
<div style="margin-top:2ex">
Austin LK, Jaslow R, Avery T, et al. Clinical utility of circulating tumor DNA (ctDNA) in advanced and metastatic breast cancer. Paper presented at: 2015 AACR Annual Meeting. Abstract #4928. 2015.
</div>
<div style="margin-top:2ex">
Piccioni DE, Lanman RB, Nagy RJ, Talasaz A, Pingle SC, Kesari S. Analysis of cell-free circulating tumor DNA in patients with glioblastoma and other primary brain tumors. Paper presented at: 2015 ASCO Annual Meeting. J Clin Oncol 33, 2015 (suppl; abstr 11072). 2015.
</div>
<div style="margin-top:2ex">
<a href="/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRC5FR0JORF95d-3Ws8Gpw-PSB7gW." title="Heatherton TF, Kozlowski LT, Frecker RC, Fagerstr&#246;m KO. The Fagerstr&#246;m Test for Nicotine Dependence: a revision of the Fagerstr&#246;m Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27." onclick="openNewWindow('/ct2/bye/xQoPWwoRrXS9-i-wudNgpQDxudhWudNzlXNiZip9Ei7ym67VZRC5FR0JORF95d-3Ws8Gpw-PSB7gW.'); return false">Heatherton TF, Kozlowski LT, Frecker RC, Fagerstr&#246;m KO. The Fagerstr&#246;m Test for Nicotine Dependence: a revision of the Fagerstr&#246;m Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27.</a>
</div>
</div>
<br/>
<!-- Derived References -->
<table class="tr-layout_table" style="margin-top:1ex;">
<caption>Layout table for additonal information</caption>
<thead>
<tr>
<th id="colTitle1"></th>
<th id="colData1"></th>
</tr>
</thead>
<tr style="vertical-align:top;">
<td headers="colTitle1" style="white-space:nowrap;">Responsible Party:</td>
<td headers="colData1" style="padding-left:1em">Wake Forest University Health Sciences</td>
</tr>
<tr style="vertical-align:top;">
<td headers="colTitle1" style="white-space:nowrap;">ClinicalTrials.gov Identifier:</td>
<td headers="colData1" style="padding-left:1em">
<a class="tr-study-link" title="Current version of study NCT03746262 on ClinicalTrials.gov" href="https://clinicaltrials.gov/show/NCT03746262">NCT03746262</a> &nbsp; &nbsp;
<a class="tr-study-link" href="/ct2/archive/NCT03746262"
title="Historical versions of study NCT03746262 on ClinicalTrials.gov Archive Site"
onclick="openNewWindow('/ct2/archive/NCT03746262'); return false;">History of Changes</a>
</td>
</tr>
<tr style="vertical-align:top;">
<td headers="colTitle1" style="white-space:nowrap;">Other Study ID Numbers:</td>
<td headers="colData1" style="padding-left:1em">
IRB00036520 <br/>
<a href="https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P30CA012197&Fy=all" title="Additional information available on NIH RePORTER" onclick="openNewWindow('https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P30CA012197&Fy=all'); return false">
P30CA012197 ( U.S. NIH Grant/Contract )</a><br/>
CCCWFU 62A15 ( Other Identifier: NCI )<br/>
</td>
</tr>
<tr style="vertical-align:top;">
<td headers="colTitle1" style="white-space:nowrap;">First Posted:</td>
<td headers="colData1" style="padding-left:1em">November 19, 2018
&nbsp;&nbsp;
<a class="tr-study-link" href="/ct2/keydates/NCT03746262"
title="View key record dates for NCT03746262"
onclick="openNewWindow('/ct2/keydates/NCT03746262'); return false;">Key Record Dates</a>
</td>
</tr>
<tr style="vertical-align:top;">
<td headers="colTitle1" style="white-space:nowrap;">Last Update Posted:</td>
<td headers="colData1" style="padding-left:1em">November 21, 2018
</td>
</tr>
<tr style="vertical-align:top;">
<td headers="colTitle1" style="white-space:nowrap;">Last Verified:</td>
<td headers="colData1" style="padding-left:1em">November 2018
</td>
</tr>
<!-- Plan to Share Data -->
<tr style="vertical-align:top;">
<td headers="colTitle1" colspan="2" style="padding-top:3ex;white-space:nowrap;">Individual Participant Data (IPD) Sharing Statement:</td>
</tr>
<tr style="vertical-align:top;">
<td headers="colTitle1" style="text-align:right;white-space:nowrap;">Plan to Share IPD:</td>
<td headers="colData1" style="padding-left:1em">No</td>
</tr>
</table>
<br/>
<table class="tr-layout_table" style="margin-top:1ex">
<caption>Layout table for additional information</caption>
<thead>
<tr>
<th id="colTitle2"></th>
<th id="colData2"></th>
</tr>
<tr style="vertical-align:top;">
<td headers="colTitle2" colspan="2" style="white-space:nowrap;">Studies a U.S. FDA-regulated Drug Product:</td>
<td headers="colData2" style="padding-left:1em">No</td>
</tr>
<tr style="vertical-align:top;">
<td headers="colTitle2" colspan="2" style="white-space:nowrap;">Studies a U.S. FDA-regulated Device Product:</td>
<td headers="colData2" style="padding-left:1em">No</td>
</tr>
</thead>
</table>
<!-- keywords -->
<br/>
Keywords provided by Wake Forest University Health Sciences:
<div class="tr-indent3">
<table class="tr-layout_table" style="width:100%;">
<thead>
<tr>
<th id="keywordCol1" style="width:50%;"></th>
<th id="keywordCol2" style="width:50%;"></th>
</tr>
</thead>
<tr style="vertical-align:top;">
<td headers="keywordCol1">
Non-Metastatic Non-Small Cell Lung Cancer<br/>
Cancer<br/>
Lung Cancer<br/>
circulating tumor-specific DNA (ctDNA)<br/>
non-invasive diagnostic<br/>
</td>
<td></td>
</tr>
</table>
</div>
<!-- mesh terms -->
<br/>
Additional relevant MeSH terms:
<div class="tr-indent3">
<table class="tr-layout_table" style="width:100%;">
<caption>Layout table for MeSH terms</caption>
<thead>
<tr>
<th id="meshTermCol1" style="width:50%;"></th>
<th id="meshTermCol2" style="width:50%;"></th>
</tr>
</thead>
<tr style="vertical-align:top;">
<td headers="meshTermCol1">
Lung Neoplasms<br/>
Carcinoma, Non-Small-Cell Lung<br/>
Respiratory Tract Neoplasms<br/>
Thoracic Neoplasms<br/>
Neoplasms by Site<br/>
</td>
<td headers="meshTermCol1" style="padding-left:1em">
Neoplasms<br/>
Lung Diseases<br/>
Respiratory Tract Diseases<br/>
Carcinoma, Bronchogenic<br/>
Bronchial Neoplasms<br/>
</td>
</tr>
</table>
</div>
<br/>
<!--
<span class="ct-body3">ClinicalTrials.gov processed this record on May 24, 2019</span><br/>
-->
<br/>
</div>
</div>
<div id="to-top"><a href="#wrapper">To Top</a></div>
<div style="clear:both;"></div>
</div>
</div>
</div>
<div> <div id="for-footer">
<ul class="ct-horz-list">
<li style="border-left:0;"><a href="/ct2/help/for-patient">For Patients and Families</a></li>
<li><a href="/ct2/help/for-researcher">For Researchers</a></li>
<li><a href="/ct2/help/for-manager">For Study Record Managers</a></li>
</ul>
</div>
</div>
<div id="footer-menu">
<ul class="ct-horz-list">
<li><a href="/ct2/home">Home</a></li>
<li><a href="/ct2/resources/rss">RSS Feeds</a></li>
<li><a href="/ct2/sitemap">Site Map</a></li>
<li><a href="/ct2/about-site/terms-conditions">Terms and Conditions</a></li>
<li><a href="/ct2/about-site/disclaimer">Disclaimer</a></li>
<li><a href="https://support.nlm.nih.gov/knowledgebase/category/?id=CAT-01242&amp;category=clinicaltrials.gov&amp;hd_url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03746262%3Fterm%3DGuardant%2BHealth" onclick="openNewWindow('https://support.nlm.nih.gov/knowledgebase/category/?id=CAT-01242&amp;category=clinicaltrials.gov&amp;hd_url=https%3A%2F%2Fclinicaltrials.gov%2Fct2%2Fshow%2FNCT03746262%3Fterm%3DGuardant%2BHealth'); return false">Customer Support</a></li>
</ul>
</div>
</div>
<div id="fine-print">
<ul class="ct-horz-list">
<li ><a title="NLM copyright information - opens new window" href="https://www.nlm.nih.gov/copyright.html" onclick="openNewWindow('https://www.nlm.nih.gov/copyright.html'); return false"
>Copyright</a></li>
<li ><a title="NLM privacy policy - opens new window" href="https://www.nlm.nih.gov/privacy.html" onclick="openNewWindow('https://www.nlm.nih.gov/privacy.html'); return false"
>Privacy</a></li>
<li ><a href="/ct2/accessibility" title="NLM Accessibility">Accessibility</a></li>
<li ><a title="NLM viewers and players - opens new window" href="https://www.nlm.nih.gov/plugins.html" onclick="openNewWindow('https://www.nlm.nih.gov/plugins.html'); return false"
>Viewers and Players</a></li>
<li ><a title="NIH Freedom of Information Act office - opens new window" href="https://www.nih.gov/icd/od/foia/index.htm" onclick="openNewWindow('https://www.nih.gov/icd/od/foia/index.htm'); return false"
>Freedom of Information Act</a></li>
<li ><a title="USA.gov - opens new window" href="https://www.usa.gov/" onclick="openNewWindow('https://www.usa.gov/'); return false"
>USA.gov</a></li>
</ul>
<ul class="ct-horz-list">
<li><a title="U.S. National Library of Medicine - opens new window" href="https://www.nlm.nih.gov/" onclick="openNewWindow('https://www.nlm.nih.gov/'); return false"
>U.S. National Library of Medicine</a></li>
<li><a title="U.S. National Institutes of Health - opens new window" href="https://www.nih.gov/" onclick="openNewWindow('https://www.nih.gov/'); return false"
>U.S. National Institutes of Health</a></li>
<li><a title="U.S. Department of Health and Human Services - opens new window" href="https://www.hhs.gov/" onclick="openNewWindow('https://www.hhs.gov/'); return false"
>
U.S. Department of Health and Human Services</a></li>
</ul>
</div>
<script type="text/javascript">__ncbi_sg_gaMode="clinicaltrials"</script>
<script type="text/javascript" src="/ct2/html/js/instrumentNCBIBaseJS.min.js?v=1"></script><noscript></noscript>
<script type="text/javascript" src="/ct2/html/js/main-glossary.js"></script><noscript></noscript>
</body>
</html>