Changes in Circulating Tumor-Specific DNA in Patients With Non-Metastatic Non-Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT03746262 |
Recruitment Status :
Completed
First Posted : November 19, 2018
Last Update Posted : November 21, 2018
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Condition or disease |
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Non Small Cell Lung Cancer |
Study Type : | Observational |
Actual Enrollment : | 40 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer |
Actual Study Start Date : | May 13, 2016 |
Actual Primary Completion Date : | August 10, 2018 |
Actual Study Completion Date : | August 10, 2018 |
Group/Cohort |
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Patients - Stage I treated with surgery
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.
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Patients - Stage I treated with radiotherapy
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.
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Patients - Stage II treated with surgery & chemotherapy
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.
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Patients - Stage III treated with chemoradiotherapy
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.
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- Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC [ Time Frame: up to 12 months ]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.
- Change in ctDNA levels in patients with Stage III NSCLC [ Time Frame: up to 12 months ]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.
- Change in ctDNA by treatment group [ Time Frame: up to 12 months ]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.
- Health Related Quality of Life- (HRQL) [ Time Frame: up to 12 months ]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.
- Number of Packs Smoked Per Day [ Time Frame: up to 12 months ]The number of packs of tobacco participants smoked per day will be assessed and recorded
- Number of Years Smoked [ Time Frame: up to 12 months ]The number of years participants smoked will be recorded.
- Number of Participants that have a Smoking Status [ Time Frame: up to 12 months ]Participants will be asked about their current smoking status (yes/no). These answers will be recorded.
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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).
- 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.
- Ability to provide blood sample at the following time points: pre-treatment, 1 month post definitive treatment, and 4 post definitive treatment.
- Ability to understand and the willingness to sign an IRB-approved informed consent document.
- 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.
Exclusion Criteria:
- Females who are pregnant
- History of organ transplant.
- For stage II and III patients, must be able to receive chemotherapy.
- Active cardiovascular issues in the past 6 months.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03746262
United States, North Carolina | |
Wake Forest Baptist Medical Center | |
Winston-Salem, North Carolina, United States, 27157 |
Principal Investigator: | Stefan Grant, MD | Wake Forest University Health Sciences |
Publications:
Responsible Party: | Wake Forest University Health Sciences |
ClinicalTrials.gov Identifier: | NCT03746262 History of Changes |
Other Study ID Numbers: |
IRB00036520 P30CA012197 ( U.S. NIH Grant/Contract ) CCCWFU 62A15 ( Other Identifier: NCI ) |
First Posted: | November 19, 2018 Key Record Dates |
Last Update Posted: | November 21, 2018 |
Last Verified: | November 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No | |
Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Wake Forest University Health Sciences:
Non-Metastatic Non-Small Cell Lung Cancer Cancer Lung Cancer circulating tumor-specific DNA (ctDNA) non-invasive diagnostic |
Additional relevant MeSH terms:
Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |