Clinical trial · Observational
Biomarkers for Risk Stratification in Lung Cancer
Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening
NCT03774758CI-TRIAL-00113695recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nodule Solitary Pulmonary | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Guardant Health ct-DNA LUNAR assay | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- label
- Cohort 1A: Benign nodule on screening CT
- description
- High-risk patients eligible for lung cancer screening but with negative radiographic findings on CT screening (Lung RADS ≤2). 1. ≥30 pack-year history of cigarette smoking 2. ≥55 years of age 3. Current smoker or quit within the past 15 years
- interventionNames
- Diagnostic Test: Guardant Health ct-DNA LUNAR assay
- label
- Cohort 1B: Incidental benign nodule
- description
- Patients with lung nodules ≥ 6 mm on routine (non-lung cancer screening) CT evaluation deemed suspicious for malignancy by initial physician judgment but not malignant by ≥2 years of radiographic stability and consensus clinical opinion. 1- Age ≥40 years.
- interventionNames
- Diagnostic Test: Guardant Health ct-DNA LUNAR assay
- label
- Cohort IC: Presumed lung cancer
- description
- Patients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy. 1- Age ≥40 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.