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
This trial does not accept healthy volunteersQualifiers
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 population
This is a prospective observational study that will follow patients who undergo lung cancer screening at the San Francisco VA Medical Center, UCSF Medical Center, and the San Francisco General Hospital.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Guardant Health ct-DNA LUNAR assay
Diagnostic testGuardant 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.
Treatment groups
590 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Group A: Cohort 1A: Benign nodule on screening CT1 intervention
Group B: Cohort 1B: Incidental benign nodule1 intervention
Group C: Cohort IC: Presumed lung cancer1 intervention
Group D: Cohort 2A: Suspicious nodule1 intervention
Group E: Cohort 2B: Suspicious incidental nodule1 intervention
Group F: Cohort 2C: Post-treatment lung cancer1 intervention
Trial outcomes
Primary outcomes
1
Sensitivity and specificity of ct-DNA LUNAR Assay
Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion\* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up\*\*. \*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.
Time frame
Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.2
Prospective negative predictive value of ct-DNA LUNAR assay
Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).
Time frame
Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, San Francisco
Lead sponsor
Northern California Institute of Research and Education
Collaborator
Guardant Health, Inc.
Collaborator
Source ClinicalTrials.gov