EQUAL: EGFR ctDNA QUantative Assessment for Lung Cancer Screening in Asian and Latinx Populations
Dana-Farber Cancer Institute
1,000 participants
Apr 1, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria16
- 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.
Exclusion Criteria9
- 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
Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06716580