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
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 eligibility, in-clinic visits, blood tests, and an optional questionnaire and/or focus group. It is expected that about 1000 people will participate in the blood sample collection, 100 individuals in the survey, and 20 individuals in the focus groups.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
1,000
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.
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
NOT_YET_RECRUITINGDana-Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
Detection Rate of Non-Small Cell Lung Cancer
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.
Time frame: 2 years
Testing Turnaround Time
The duration from the time of blood draw to the release of the ctDNA testing results to the study team.
Time frame: Up to 2 years
Recruitment Acceptability
Determining proportion of screened patients who are eligible and who consent to the trial at each collaboration site
Time frame: Up to 2 years
Barriers to Sample Acquisition
Examining barriers impeding scale-up of sample collection, handling, and delivery
Time frame: Up to 2 years
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Dana-Farber Cancer Institute at Steward St. Elizabeth's
Brighton, Massachusetts, United States
NOT_YET_RECRUITINGDana-Farber Cancer Instiute Merrimack Valley
Methuen, Massachusetts, United States
NOT_YET_RECRUITINGDana-Farber Cancer Institute South Shore
South Weymouth, Massachusetts, United States
NOT_YET_RECRUITING