Blood test for screening EGFR positive lung cancer in at-risk populations
EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations
This study is testing a new blood test to see if it can help find EGFR positive lung cancer early in healthy people from East Asian and Latinx backgrounds who are at risk and can't have regular screenings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 6 sites (Boston, Massachusetts and 5 other locations) |
| Trial ID | NCT06716580 on ClinicalTrials.gov |
What this trial studies
This research evaluates a new blood test designed to screen for Epidermal Growth Factor Receptor (EGFR) positive lung cancer in healthy individuals who are at risk and cannot undergo standard lung cancer screening. The study focuses on East Asian and Latinx participants, assessing the feasibility of a circulating free DNA (cfDNA) assay that detects specific EGFR mutations. Participants will undergo blood tests, in-clinic visits, and may also take part in surveys or focus groups to provide additional insights. The study aims to determine if this blood test can effectively identify lung cancer before symptoms appear.
Who should consider this trial
Good fit: Ideal candidates are healthy individuals aged 40 to 80 who self-identify as East Asian or Hispanic/Latinx and are non-tobacco users.
Not a fit: Patients who are not part of the East Asian or Hispanic/Latinx populations or those who are current tobacco users may not benefit from this study.
Why it matters
Potential benefit: If successful, this blood test could provide an early detection method for lung cancer in populations that are currently underserved by traditional screening methods.
How similar studies have performed: Other studies have shown promise in using ctDNA assays for cancer detection, but this specific approach targeting EGFR mutations in these populations is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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. Inclusion Criteria (Aims 1, 2, and 3) for Group 2 (40 through 49 years of age): * 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. Exclusion Criteria (Aims 1, 2, and 3) for Groups 1 and 2: * Having had a chest CT scan in the last 3 years or having an anticipated chest CT scan during the enrollment period. * Having a current cancer or history of cancer within the last 5 years, excluding localized non-melanoma skin cancer and breast ductal carcinoma in situ. * More than 400 lifetime cigarettes (i.e., 20 packs) of smoking or tobacco use * Adults unable to provide informed consent * Individuals \<40 years of age * Prisoners * Pregnant women * Personal diagnosis of lung cancer * Not able to be compliant with study requirements
Where this trial is running
Boston, Massachusetts and 5 other locations
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Massachusetts General Hospital — Boston, Massachusetts, United States (Not_yet_recruiting)
- Dana-Farber Cancer Institute at Steward St. Elizabeth's — Brighton, Massachusetts, United States (Not_yet_recruiting)
- Dana-Farber Cancer Instiute Merrimack Valley — Methuen, Massachusetts, United States (Not_yet_recruiting)
- Dana-Farber Cancer Institute South Shore — South Weymouth, Massachusetts, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Narjust Florez, MD — Dana-Farber Cancer Institute
- Study coordinator: Jennifer Lee
- Email: jennifer_lee2@dfci.harvard.edu
- Phone: 857-215-2795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.