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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: t
View:

• 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 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean

• Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.

• Non-tobacco using (currently)

• Self-identify as East Asian (including Southeast Asian) or Latinx, if any of the following criteria are met:

‣ Family history of EGFR positive LC L858R or exon 19

⁃ Personal history of remote cancer that is not LC or other thoracic malignancies, including thymoma, thymic carcinoma, or sarcoma, as long as it was resolved over 5 years ago

⁃ History of TB, asthma requiring daily inhaled corticosteroids or chronic bronchitis

⁃ Symptoms of lung cancer for the past month, including hemoptysis, unexplained weight loss, voice hoarseness, cough or worsening cough, dyspnea or worsening dyspnea

• Excluding individuals who concurrently present with fever, covid/influenza/RSV/adenovirus infection, runny nose, sore throat, productive cough with green or yellow sputum

• Aims 1 and 2: Able to complete and understand the study's informed consent in English, Mandarin, Cantonese, Japanese, Korean, Vietnamese, Spanish, Portuguese, or Cape Verdean

• Aim 3: Able to complete and understand the study's informed consent and participate in a focus group in English, Mandarin, Vietnamese, or Spanish.

Locations
United States
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Dana-Farber Cancer Institute
RECRUITING
Boston
Massachusetts General Hospital
NOT_YET_RECRUITING
Boston
Dana-Farber Cancer Institute at Steward St. Elizabeth's
NOT_YET_RECRUITING
Brighton
Dana-Farber Cancer Instiute Merrimack Valley
NOT_YET_RECRUITING
Methuen
Dana-Farber Cancer Institute South Shore
NOT_YET_RECRUITING
South Weymouth
Contact Information
Primary
Narjust Florez, MD
narjust_florez@dfic.harvard.edu
617-582-7335
Time Frame
Start Date: 2025-04-01
Estimated Completion Date: 2030-09-01
Participants
Target number of participants: 1000
Treatments
Experimental: ctDNA Assay
All participants will be asked to provide blood samples and are administered a baseline questionnaire. The blood sample will be tested using the investigational ctDNA assay. If the investigational test is positive, these participants will be followed up by CLIA verification of results. A positive 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. Participants will be notified of results.~Additionally, participants may participant in optional studies: 1) One-time survey regarding perception of lung cancer screening and ctDNA testing, 2) Virtual focus group, 3) Blood banking study
Related Therapeutic Areas
Sponsors
Collaborators: Boston Medical Center, Massachusetts General Hospital, Beth Israel Deaconess Medical Center
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov