This clinical trial studies whether a new blood test can detect a specific type of lung cancer (LC) early in non-tobacco using Asian and Latinx individuals. Human bodies are made up of cells with genes that regulate their growth and function. When changes, known as "alterations," occur in these genes, cells can start growing uncontrollably and spreading, leading to cancer. Sometimes, these cancer cells, along with their mutated genetic material, can enter the bloodstream. The new blood test used in this trial allows for the detection of these mutations, specifically mutations in epidermal growth factor receptor (EGFR). EGFR is a gene change which can be present in a specific type of LC. EGFR is often found in non-tobacco using, East Asian or Hispanic individuals who are not eligible for routine LC screening with current guidelines. EGFR-related LC is often diagnosed at a very advanced stage when the cancer has traveled outside of the lung. Using the new blood test may help detect EGFR mutations and LC earlier in non-tobacco using Asian and Latinx individuals, which may allow for more treatment options.
Additional locations may be listed on ClinicalTrials.gov for NCT06716580.
Locations matching your search criteria
United States
Massachusetts
Boston
Dana-Farber Cancer InstituteStatus: Active
Contact: Narjust Florez
PRIMARY OBJECTIVES:
I. Determine the feasibility of EGFR plasma circulating tumor-derived deoxyribonucleic acid (ctDNA) screening to identify early to locally advanced EGFR-positive (EGFRm)-non-small cell lung carcinoma (NSCLC) among non-tobacco using, healthy East Asian (including Southeast Asian) and Latinx individuals at risk for lung cancer, including family members of patients with a diagnosis of EGFR-positive NSCLC. (Phase One)
II. To utilize mixed-methods to gain insight into the perceptions of LC screening, knowledge about LC in non-tobacco users, and barriers and facilitators to our assay’s deployment among East Asian (including Southeast Asian) and Latinx individuals, via a survey. (Phase Two)
III. To utilize mixed-methods to gain insight into the perceptions of LC screening, knowledge about LC in non-tobacco users, and barriers and facilitators to our assay’s deployment among East Asian (including Southeast Asian) and Latinx individuals, via focus groups. (Phase Two)
OUTLINE:
Participants undergo blood sample collection and droplet digital polymerase chain reaction (ddPCR) testing on study. Participants with negative test results receive notification via email, phone, or letter on study. Participants with positive test results undergo confirmation testing, computed tomography (CT), and, if needed, receive a referral to lung nodule clinic for further workup on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationDana-Farber Harvard Cancer Center
Principal InvestigatorNarjust Florez
