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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT06716580
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • Circulating Tumor DNA (ctDNA) Assay — DEVICE
    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.

Study Details

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

Key Dates

Start date
Apr 1, 2025
Status verified
Aug 2025
Primary completion
Sep 1, 2027
Completion
Sep 1, 2030

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING

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

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Daniel Costa, MD, PhD
[email protected]
617-667-7000
Daniel Costa, MD, PhD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Narjust Florez, MD
[email protected]
617-582-7335
Narjust Florez, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02215
Lecia Sequist, MD, MPH
[email protected]
617-726-5130
Lecia Sequist, MD, MPH (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute at Steward St. Elizabeth'sBrightonMassachusetts02135
Alys Malcolm, MD
[email protected]
617-632-4595
Alys Malcolm, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Instiute Merrimack ValleyMethuenMassachusetts01844
Pedro Sanz-Altamira, MD
[email protected]
978-620-2020
Pedro Sanz-Altamira, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer Institute South ShoreSouth WeymouthMassachusetts02190
Shail Maingi, MD
[email protected]
781-624-5000
Shail Maingi, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
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By specialty
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By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MADana-Farber Cancer Institute at Steward St. Elizabeth's· Brighton, MADana-Farber Cancer Instiute Merrimack Valley· Methuen, MADana-Farber Cancer Institute South Shore· South Weymouth, MA

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