Recruiting

Risk Stratification

Sponsor:

UCLA

Code:

NCT03774758

Conditions

Nodule Solitary Pulmonary

Non-small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Guardant Health ct-DNA LUNAR assay

Study Details

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.

Conditions

Nodule Solitary Pulmonary

Non-small Cell Lung Cancer

Study ID

NCT03774758

Start date

Dec 17, 2017

Status verified date

Jun, 2026

Completion date

Dec 31, 2030

Anticipated

Primary completion date

Dec 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

590 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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.

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.

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

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.

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.

Interventions

Guardant 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.

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. ]
  • Prospective negative predictive value 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 and Locations

Central contacts

Mehrdad Arjomandi, MD

877-827-3222cancertrials@ucsf.edu

Locations

Zuckerberg San Francisco General Hospital and Trauma Center

Recruiting

San Francisco, California, United States, 94110

Contacts

Mehrdad Arjomandi, MD

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Mehrdad Arjomandi, M.D.

San Francisco VA Medical Center

Recruiting

San Francisco, California, United States, 94121

Contacts

Mehrdad Arjomandi, M.D.

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Mehrdad Arjomandi, M.D.

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94122

Contacts

Mehrdad Arjomandi, MD

877-827-3222cancertrials@ucsf.edu

Principal Investigator:

Mehrdad Arjomandi, M.D.

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 4, 2026

Last verified

Jun, 2026

Keywords

  • Lung cancer screening
  • Biomarkers of lung cancer
  • Circulating tumor DNA
  • Low dose computed tomography of lung
  • Pulmonary nodule

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-04.