A Pilot Study of Changes in Circulating Tumor-Specific DNA (ctDNA) in Patients With Non-Metastatic Non-Small Cell Lung Cancer
Sponsor study identifier
Secondary identifiers
NIH
OTHER · NCI
observational
40
1 country
1
Study Start
May 13, 2016
Actual (reported)Primary Completion
August 10, 2018
Actual (reported)Study Completion
August 10, 2018
Actual (reported)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 Participants will have approximately 3 teaspoons of blood withdrawn from a vein at three different times.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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 10, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 13, 2016
Actual (reported)August 10, 2018
Actual (reported)August 10, 2018
Actual (reported)November 12, 2018
Actual (reported)November 19, 2018
Actual (reported)Change in ctDNA levels in patients with Stage I or II (Non-small cell lung cancer) NSCLC
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.
up to 12 months
Change in ctDNA levels in patients with Stage III NSCLC
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.
up to 12 months
Change in ctDNA by treatment group
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.
up to 12 months
Health Related Quality of Life- (HRQL)
up to 12 months
Number of Packs Smoked Per Day
up to 12 months
Number of Years Smoked
up to 12 months
Number of Participants that have a Smoking Status
up to 12 months
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.
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.
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.
Men and women of all races and ethnicities who meet the above-described eligibility criteria are eligible to participate in this study.
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
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. doi: 10.1023/a:1006260319913.
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.
whole blood and tissue when available
Stefan Grant, MD
Wake Forest University Health Sciences
40 participants (actual enrollment reported by the registry).
First Submitted
November 12, 2018
First Posted
November 19, 2018
Study Start
May 13, 2016
Actual (reported)A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)
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.
Contact the study team to confirm eligibility.
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Primary Completion
August 10, 2018
Actual (reported)Study Completion
August 10, 2018
Actual (reported)Last Updated
November 21, 2018
Record last verified: 2018-11
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