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

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer; EGFR Gene Mutation

• Registration Number: NCT06716580
• Lead Sponsor: Dana-Farber Cancer Institute

Brief 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

Detailed Description

The goal of this research study is to evaluate the feasibility of a novel EGFR blood plasma ctDNA screening test among East Asian and Latinx participants at risk for lung cancer and ineligible for regular lung cancer screening. The test looks for a gene change called Epidermal Growth Factor Receptor (EGFR), specifically EGFR L858R and exon 19 deletions, whic...

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Study Start: 2025-01
• Primary Completion: 2026-11-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Detection Rate of Non-Small Cell Lung Cancer	2 years	The proportion of participants with a positive assay result who are subsequently diagnosed with lung cancer through clinical pathology, among all participants tested with the assay.

Secondary Outcome Measures

Name	Time	Method
Stage of Detected Lung Cancer	2 years	The clinical stage of lung cancer diagnosed after clinical workup, graded using National Comprehensive Cancer Network (NCCN) guidelines.
Rate of Asymptomatic or Mildly Symptomatic Lung Cancer	2 years	The proportion of participants with detected lung cancer who report to be asymptomatic or have mildly symptomatic (defined as not exhibiting symptoms that would prompt clinical assessment, per participant report) at the time of ctDNA testing.
Testing Turnaround Time	Up to 2 years	The duration from the time of blood draw to the release of the ctDNA testing results to the study team.
Mutation Distribution	Up to 2 years	Distribution analysis of EGFR L858R and exon 19 deletions detected by ctDNA assay
Recruitment Acceptability	Up to 2 years	Determining proportion of screened patients who are eligible and who consent to the trial at each collaboration site
Barriers to Sample Acquisition	Up to 2 years	Examining barriers impeding scale-up of sample collection, handling, and delivery

Trial Locations

Locations (7)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute at Steward St. Elizabeth's; 🇺🇸 Brighton, Massachusetts, United States

Dana-Farber Cancer Instiute Merrimack Valley; 🇺🇸 Methuen, Massachusetts, United States

Dana-Farber Cancer Institute South Shore; 🇺🇸 South Weymouth, Massachusetts, United States