EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations
Dana-Farber Cancer Institute
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
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, which comprise 85-90% of total EGFR mutations. This study seeks to determine if it is possible to use the blood test to detect this type of lung cancer that might not yet show symptoms. The research study procedures include screening for eligi…
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria (Aims 1, 2, and 3) for Group 1 (50 through 80 years of age): * Non-tobacco using (currently) * Self-identify as East Asian (including Southeast Asian) or Hispanic/Latinx. * East Asian includes those who self-identify as Chinese, Japanese, Korean, Taiwanese, Malaysian * Southeast Asian includes those who self-identify as Cambodian, Thai, Vietnamese, Filipino * Latinx includes those who self-identify as a person of Central or South American and the Caribbean including, Cuban, Puerto Rican, and Dominican culture or origin, excluding individuals originating from Spain * Aims 1…
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.
Locations (6)
- Beth Israel Deaconess Medical CenterBoston, Massachusetts
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Massachusetts General HospitalBoston, Massachusetts
- Dana-Farber Cancer Institute at Steward St. Elizabeth'sBrighton, Massachusetts
- Dana-Farber Cancer Instiute Merrimack ValleyMethuen, Massachusetts
- Dana-Farber Cancer Institute South ShoreSouth Weymouth, Massachusetts