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Biomarkers for Risk Stratification in Lung Cancer
Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening
Who can join
Ages 40 and older · All sexes
Full eligibility 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.
About the study
This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, University of California, San Francisco (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will comprise of two primary populations to determine the ctDNA assay performance in a variety of clinical settings.
What is being tested
- Guardant Health ct-DNA LUNAR assay (diagnostic test)
Sponsor: University of California, San Francisco · Participants: 590 · Started: Dec 17, 2017
Contact the study team
- Mehrdad Arjomandi, MD · Phone: 877-827-3222
Official record on ClinicalTrials.gov — NCT03774758
Locations in the U.S.
| California | San Francisco VA Medical Center, San Francisco University of California, San Francisco, San Francisco Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.