Biomarkers for Risk Stratification in Lung Cancer

NCT03774758 | Recruiting

• 2 other identifiers: 17-22915176517
• Study Type: observational
• Target: 590
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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).

  Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.

Study Arms (6)

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

Diagnostic Test: Guardant Health ct-DNA LUNAR assay

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.

Diagnostic Test: Guardant Health ct-DNA LUNAR assay

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.

Diagnostic Test: Guardant Health ct-DNA LUNAR assay

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

Diagnostic Test: Guardant Health ct-DNA LUNAR assay

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.

Diagnostic Test: Guardant Health ct-DNA LUNAR assay

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.

Diagnostic Test: Guardant Health ct-DNA LUNAR assay

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.

Also known as: Liquid biopsy Using NGS to Assay high-Risk patients

Cohort 1A: Benign nodule on screening CT; Cohort 1B: Incidental benign nodule; Cohort 2A: Suspicious nodule; Cohort 2B: Suspicious incidental nodule; Cohort 2C: Post-treatment lung cancer; Cohort IC: Presumed lung cancer

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Northern California Institute of Research and Education: collaborator
• Guardant Health, Inc.: collaborator

Study Sites (3)

Zuckerberg San Francisco General Hospital and Trauma Center

San Francisco, California, 94110, United States

RECRUITING

San Francisco VA Medical Center

San Francisco, California, 94121, United States

RECRUITING

University of California, San Francisco

San Francisco, California, 94122, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The goal of this study is to evaluate the ability of cell-free circulating tumor DNA (ctDNA) using Guardant Health's LUNAR technology to detect early stage in lung cancer as compared to healthy volunteers and those patients at high risk for lung cancer, but without a lung cancer diagnosis. ctDNA arises when DNA fragments are released into the bloodstream after cell death and is distinguished from non-cancerous cell-free DNA (cfDNA) by the presence of somatic alterations, e.g. mutations, gene amplifications, and fusions. In advanced stage non-small cell lung cancer (NSCLC), evaluation of ctDNA in plasma can be used detect the presence of resistance mutations and ultimately guide treatment while obviating the need for tissue biopsy.

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Mehrdad Arjomandi, M.D.

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehrdad Arjomandi, MD

CONTACT

877-827-3222; cancertrials@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: December 17, 2017
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)