ctDNA Assay for Lung Cancer (EQUAL Trial)

Recruiting in Palo Alto (17 mi)

+6 other locations

Overseen ByNarjust Florez, MD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?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

This trial is for healthy Asian and Latinx individuals at risk of lung cancer who can't have standard screening. It's looking to detect EGFR mutations, which are linked to certain lung cancers.

Inclusion Criteria

I am 50-80 years old, do not use tobacco, and identify as East Asian or Latinx.

Exclusion Criteria

I am unable to understand or sign the consent form.

I am younger than 40 years old.

I have not coughed up blood.

I have been diagnosed with lung cancer.

Participant Groups

The study tests a new blood test called Circulating Tumor DNA (ctDNA) Assay, designed to screen for EGFR positive lung cancer in people without symptoms.

1Treatment groups

Experimental Treatment

Group I: ctDNA AssayExperimental Treatment1 Intervention

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