Life sciences · Observational Study
ClinicalTrials.gov · October 14, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT03774758). This is a study registration, not published results. Lead sponsor: University of California, San Francisco. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 1440 participants (ESTIMATED). Conditions: Nodule Solitary Pulmonary, Non-small Cell Lung Cancer. Interventions: DIAGNOSTIC_TEST: Guardant Health ct-DNA LUNAR assay. Primary outcome measures: Sensitivity and specificity of ct-DNA LUNAR Assay , Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.; Prospective negative predictive value of ct-DNA LUNAR assay , Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.. 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 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.