Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening
University of California, San Francisco
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 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.
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 this phase, the technical feasibility of the intended use case will be assessed in the intended use population relative to known cancer status as established by standard clinical methods. ctDNA samples from enrolled patients will be assessed in each of the following cohorts: Cohort 1A: High-risk patients negative for lung cancer by CT screening and clinical follow-up. Cohort 1B: Patients with lung…
Eligibility
- Age range
- 40+ years
- Sex
- All
- Healthy volunteers
- Not specified
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 h…
Interventions
- Diagnostic TestGuardant Health ct-DNA LUNAR assay
Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease.
Locations (3)
- Zuckerberg San Francisco General Hospital and Trauma CenterSan Francisco, California
- San Francisco VA Medical CenterSan Francisco, California
- University of California, San FranciscoSan Francisco, California