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

RECRUITINGN/ASponsored by Dana-Farber Cancer Institute
Actively Recruiting
PhaseN/A
SponsorDana-Farber Cancer Institute
Started2025-04-01
Est. completion2027-09-01
Eligibility
Age40 Years – 80 Years
Healthy vol.Accepted
Locations6 sites

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

Age: 40 Years – 80 YearsHealthy volunteers accepted
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

Conditions3

CancerEGFR Gene MutationLung Cancer

Locations6 sites

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Daniel Costa, MD, PhD617-667-7000dbcosta@bidmc.harvard.edu
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Narjust Florez, MD617-582-7335narjust_florez@dfci.harvard.edu
Massachusetts General Hospital
Boston, Massachusetts, 02215
Lecia Sequist, MD, MPH617-726-5130lvsequist@mgb.org
Dana-Farber Cancer Institute at Steward St. Elizabeth's
Brighton, Massachusetts, 02135
Alys Malcolm, MD617-632-4595alys_malcolm@dfci.harvard.edu
Dana-Farber Cancer Instiute Merrimack Valley
Methuen, Massachusetts, 01844
Pedro Sanz-Altamira, MD978-620-2020pedro_sanz-altamira@dfci.harvard.edu

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