Status:
RECRUITING
Biomarkers for Risk Stratification in Lung Cancer
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Northern California Institute of Research and Education
Guardant Health, Inc.
Conditions:
Nodule Solitary Pulmonary
Non-small Cell Lung Cancer
Eligibility:
All Genders
40+ years
Brief Summary
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 Cen...
Detailed Description
Study objectives and statistical approaches to achieve those objectives are determined at the level of the populations described below: Population 1: Sensitivity and Specificity Thresholding. In thi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
590 Patients enrolled
Trial Details
Trial ID
NCT03774758
Start Date
December 17 2017
End Date
December 31 2025
Last Update
March 20 2025
Active Locations (3)
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1
Zuckerberg San Francisco General Hospital and Trauma Center
San Francisco, California, United States, 94110
2
San Francisco VA Medical Center
San Francisco, California, United States, 94121
3
University of California, San Francisco
San Francisco, California, United States, 94122