Biomarkers for Risk Stratification in Lung Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT03774758
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Guardant Health ct-DNA LUNAR assay — DIAGNOSTIC_TEST
    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.

Study Details

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.

Key Dates

Start date
Dec 17, 2017
Status verified
Jun 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
590 participants (estimated)

Arms

  • Arm: Cohort 1A: Benign nodule on screening CT
    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
  • Arm: Cohort 1B: Incidental benign nodule
    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.
  • Arm: Cohort IC: Presumed lung cancer
    Patients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy. 1- Age ≥40 years.
  • Arm: Cohort 2A: Suspicious nodule
    High-risk patients with newly diagnosed suspicious nodule of Lung RADS ≥3 on CT screening. 1. ≥30 pack-year history of cigarette smoking 2. ≥55 years of age 3. Current smoker or quit within the past 15 years
  • Arm: Cohort 2B: Suspicious incidental nodule
    Patients with newly diagnosed incidentally-found lung nodules ≥ 6 mm on routine CT evaluation deemed suspicious for malignancy by physician judgment. 1- Age ≥40 years.
  • Arm: Cohort 2C: Post-treatment lung cancer
    Patients with previously treated lung cancer (histologically proven or by consensus opinion); status-post completion of definitive therapy (resection +/- chemotherapy or SBRT with curative intent) within the previous year with no current evidence of disease. 1- Age ≥40 years.

Primary Outcome Measure

Sensitivity and specificity of ct-DNA LUNAR Assay [ Time Frame: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
San Francisco VA Medical CenterSan FranciscoCalifornia94121
Mehrdad Arjomandi, M.D.
[email protected]
877-827-3222
Mehrdad Arjomandi, M.D. (PRINCIPAL_INVESTIGATOR)
University of California, San FranciscoSan FranciscoCalifornia94122
Mehrdad Arjomandi, MD
[email protected]
877-827-3222
Mehrdad Arjomandi, M.D. (PRINCIPAL_INVESTIGATOR)
Zuckerberg San Francisco General Hospital and Trauma CenterSan FranciscoCalifornia94110
Mehrdad Arjomandi, MD
[email protected]
877-827-3222
Mehrdad Arjomandi, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
San Francisco VA Medical Center· San Francisco, CAUniversity of California, San Francisco· San Francisco, CAZuckerberg San Francisco General Hospital and Trauma Center· San Francisco, CA

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