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

Plain-language summary

This study investigates an EGFR-based test that measures circulating tumor DNA (ctDNA) in the blood for early lung cancer screening in non-smoking Asian and Latinx individuals. People who self-identify as East/Southeast Asian or Hispanic/Latinx, currently do not use tobacco, and meet certain age and risk criteria may take part. It is a non-phase study that is currently recruiting.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Not Applicable

Status

Recruiting

Sponsor

Dana-Farber Cancer Institute

Intervention

Circulating Tumor DNA (ctDNA) Assay

Start date

4/1/2025

Estimated completion

9/1/2030

Countries

United States

Related genes

Locations

• Boston, United States
• Boston, United States
• Boston, United States
• Brighton, United States
• Methuen, United States
• South Weymouth, United States

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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