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

Last updated: April 15, 2025
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cancer

Lung Disease

Lung Cancer

Treatment

Circulating Tumor DNA (ctDNA) Assay

Clinical Study ID

NCT06716580
24-415
  • Ages 40-80
  • All Genders
  • Accepts Healthy Volunteers

Study 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 Criteria

Inclusion

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

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: Circulating Tumor DNA (ctDNA) Assay
Phase:
Study Start date:
April 01, 2025
Estimated Completion Date:
December 01, 2027

Study Description

The goal of this research study is to evaluate the feasibility of a novel EGFR blood plasma ctDNA screening test among East Asian and Latinx participants at risk for lung cancer and ineligible for regular lung cancer screening. The test looks for a gene change called Epidermal Growth Factor Receptor (EGFR), specifically EGFR L858R and exon 19 deletions, which comprise 85-90% of total EGFR mutations. This study seeks to determine if it is possible to use the blood test to detect this type of lung cancer that might not yet show symptoms.

The research study procedures include screening for eligibility, in-clinic visits, blood tests, and an optional questionnaire and/or focus group.

It is expected that about 1000 people will participate in the blood sample collection, 100 individuals in the survey, and 20 individuals in the focus groups.

Connect with a study center

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Boston Medical Center

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • Dana-Farber Cancer Institute at Steward St. Elizabeth's

    Brighton, Massachusetts 02135
    United States

    Site Not Available

  • Dana-Farber Cancer Instiute Merrimack Valley

    Methuen, Massachusetts 01844
    United States

    Site Not Available

  • Dana-Farber Cancer Institute South Shore

    South Weymouth, Massachusetts 02190
    United States

    Site Not Available

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