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Observational Study on Biomarkers for Lung Cancer Risk

This observational study is looking at how well a blood test, called the Guardant Health ct-DNA LUNAR assay, can help identify people at risk for lung cancer. Researchers are studying people who have a solitary pulmonary nodule (a small spot on the lung) or non-small cell lung cancer. The goal is to see how accurately this blood test can detect lung cancer or predict who will develop it, compared to standard methods like CT scans and biopsies. You may be able to join if you are 40 years or older, can give blood samples, and are willing to be followed for three years. The study aims to enroll about 590 participants across several medical centers.

Study design
This is an observational study with a planned enrollment of 590 participants. It is designed to assess the performance of the Guardant Health ct-DNA LUNAR assay in different groups of patients.
What's involved
You would need to provide blood samples and be willing to complete three years of clinical follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for three years after enrollment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03774758

Biomarkers for Risk Stratification in Lung Cancer

Recruiting
Not specifiedAges 40+Observational
University of California, San Francisco
~590 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:Guardant Health ct-DNA LUNAR assay

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity and specificity of ct-DNA LUNAR Assay
Measured over Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
+1 more outcome measured

Conditions

Nodule Solitary Pulmonary
Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell CarcinomaPulmonary Nodule

Where it's being run

3 sites across 1 states
California3

Study leadership

  • Mehrdad Arjomandi, M.D. · PRINCIPAL_INVESTIGATOR · University of California, San Francisco

Who to contact

Mehrdad Arjomandi, MD
[email protected]
877-827-3222
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Eligibility criteria

Inclusion

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

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.
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.

What this trial measures

  • Sensitivity and specificity of ct-DNA LUNAR AssayExtended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.

    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.

  • Prospective negative predictive value of ct-DNA LUNAR assayExtended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.

    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).