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

Launched by DANA-FARBER CANCER INSTITUTE · Nov 29, 2024

Keywords

ClinConnect Summary

The EQUAL trial is looking at a new blood test called the Circulating free DNA (cfDNA) Assay to help screen for a type of lung cancer known as EGFR-positive lung cancer. This study is specifically focused on healthy individuals at risk for lung cancer who cannot take part in standard lung cancer screenings. The trial is open to people aged 40 to 80 who identify as East Asian or Hispanic/Latinx and meet certain health criteria, like not currently using tobacco. For those aged 40 to 49, additional eligibility includes having a family history of specific lung cancer types or certain health conditions.

If you or a loved one are eligible and decide to participate, you can expect to provide a blood sample for the test and complete some questionnaires. The study is currently recruiting participants, and it is important that all potential participants can read and understand the informed consent documents in languages such as English, Mandarin, Spanish, and others. This trial aims to find out if this new blood test can effectively identify those at risk for lung cancer, which could lead to earlier detection and better outcomes.

Gender

ALL

Eligibility 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