Biomarkers for Risk Stratification in Lung Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Active non-cutaneous malignancy within the past 5 years as per medical record or patient report.
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.
Trial design
Treatments tested in this trial
- Guardant Health ct-DNA LUNAR assay
Treatment groups
590 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
University of California, San Francisco
Lead sponsor
Northern California Institute of Research and Education
Collaborator
Guardant Health, Inc.
Collaborator
Source ClinicalTrials.gov