RecruitingNot ApplicableNCT06716580

EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations

Sponsor

Dana-Farber Cancer Institute

Enrollment

1,000 participants

Start Date

Apr 1, 2025

Study Type

INTERVENTIONAL

Conditions

Lung Cancer EGFR Gene Mutation

Summary

This research study is studying a new blood test to screen for Epidermal Growth Factor Receptor (EGFR) positive lung cancer in healthy individuals at risk for the disease and who cannot undergo regular lung cancer screening. The name of the test used in this research study is: -Circulating free DNA (cfDNA) Assay

Eligibility

Min Age: 40 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study (EQUAL) is testing a blood-based DNA test (looking at EGFR mutations in circulating tumor DNA) for lung cancer screening in East Asian and Hispanic/Latinx populations who do not smoke. These groups are known to develop lung cancer even without smoking, often due to EGFR gene mutations. **You may be eligible if...** - You are 50–80 years old and do not currently smoke - You identify as East Asian (including Southeast Asian) or Hispanic/Latinx - (If aged 40–49) You have a family history of EGFR-positive lung cancer, or other risk factors like prior cancer, TB, asthma, or symptoms of lung cancer - You are able to provide informed consent in one of the supported languages **You may NOT be eligible if...** - You are a current smoker - You do not identify as East Asian, Southeast Asian, or Hispanic/Latinx - You do not meet the age and risk criteria Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECirculating Tumor DNA (ctDNA) Assay

Screening investigational blood test to test for EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. A positive or indeterminate investigational test will be followed up by CLIA verification of results. A positive or indeterminate CLIA result will be followed up by a lung CT scan. A positive CT scan will be followed up by referral for further evaluation. A negative CT scan will be followed up by a repeat scan in 12 months.