Recruiting

ctDNA Assessment

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06716580

Conditions

Lung Cancer

EGFR Gene Mutation

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Accepted

Interventions

Circulating Tumor DNA (ctDNA) Assay

Study Details

Brief 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

Conditions

Lung Cancer

EGFR Gene Mutation

Study ID

NCT06716580

Start date

Apr 1, 2025

Status verified date

Jul, 2026

Completion date

Sep 1, 2030

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy 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

Study Design

Enrollment

1000 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: ctDNA Assay

All participants will be asked to provide blood samples and are administered a baseline questionnaire. The blood sample will be tested using the investigational ctDNA assay. If the investigational test is positive, these participants will be followed up by CLIA verification of results. A positive 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. Participants will be notified of results.

Additionally, participants may participant in optional studies: 1) One-time survey regarding perception of lung cancer screening and ctDNA testing, 2) Virtual focus group, 3) Blood banking study

Interventions

Circulating Tumor DNA (ctDNA) Assay

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.

Primary outcome measure

  • Detection Rate of Non-Small Cell Lung Cancer [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Fernando Pacheco

857-215-2794fernando_pacheco@dfci.harvard.edu

Kylee Coonradt

617-582-8846kylee_coonradt@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Narjust Florez, MD

617-582-7335narjust_florez@dfci.harvard.edu

Principal Investigator:

Narjust Florez, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

  • Lung Cancer
  • EGFR Gene Mutation
  • EGFR-related lung cancer
  • EGFR positive lung cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-07-15.