Identifying biomarkers for lung cancer risk assessment
Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening
This study is testing if a blood test that looks for tumor DNA can help identify lung cancer risk in people who are being screened for the disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 590 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 3 sites (San Francisco, California and 2 other locations) |
| Trial ID | NCT03774758 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the performance of circulating tumor DNA (ctDNA) assays in patients undergoing lung cancer screening at various San Francisco medical centers. It will follow two primary populations: one assessing the sensitivity and specificity of ctDNA in patients with known cancer status, and another evaluating its clinical performance in high-risk patients suspected of having lung cancer. Participants will provide blood samples and undergo a three-year clinical follow-up to gather data on the effectiveness of the ctDNA assay compared to standard diagnostic methods.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older who are undergoing lung cancer screening and are willing to provide blood samples for analysis.
Not a fit: Patients with active non-cutaneous malignancies or severe chronic obstructive pulmonary disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance early detection and risk stratification of lung cancer, leading to improved patient outcomes.
How similar studies have performed: Other studies have shown promise in using ctDNA for cancer detection, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 40 years * Ability to understand and provide written informed consent * Willingness to comply with study protocols and provide blood samples. * Willingness to complete 3-year clinical follow up Exclusion Criteria: * Active non-cutaneous malignancy within the past 5 years as per medical record or patient report. * Exclusion criteria for possible follow-up visit blood draw: * Anemia - measured by hematocrit level of less than 30%, measured after the first blood draw. * Malnourishment - determined by BMI less than 19. If subject has BMI greater or equal to 19, but has a history of malnourishment, study staff will measure albumin level of subject's blood after initial blood draw. Albumin level must be greater than 2.5 mg per deciliter, or subject will be excluded. * Severe Chronic Obstructive Pulmonary Disease (COPD) - defined by Gold Stage IV. * Unstable heart conditions - defined by stable or unstable angina, recent myocardial infarction (within the last 2 years), active congestive heart failure, ischemic cardiomyopathy, or history of complications because of previous blood donation. * Liver cirrhosis.
Where this trial is running
San Francisco, California and 2 other locations
- Zuckerberg San Francisco General Hospital and Trauma Center — San Francisco, California, United States (Recruiting)
- San Francisco VA Medical Center — San Francisco, California, United States (Recruiting)
- University of California, San Francisco — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Mehrdad Arjomandi, M.D. — University of California, San Francisco
- Study coordinator: Mehrdad Arjomandi, MD
- Email: cancertrials@ucsf.edu
- Phone: 877-827-3222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.