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Cancer Screening Test

ctDNA Assay for Lung Cancer (EQUAL Trial)

N/A

Waitlist Available

Led By Narjust Florez, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Group 1 (50 through 80 years of age): Non-tobacco using individuals who self-identify as East Asian (including Southeast Asian) or Latinx

Be older than 18 years old

Must not have

Adults unable to provide informed consent

Individuals <40 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new blood test called Circulating free DNA (cfDNA) Assay to screen for a specific type of lung cancer in healthy individuals who are at risk for the disease but cannot

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since the intervention involves only a blood test (cfDNA Assay), there are minimal side effects, typically limited to discomfort or bruising at the needle site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable to understand or sign the consent form.

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I am younger than 40 years old.

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I have not coughed up blood.

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I have been diagnosed with lung cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Detection Rate of Non-Small Cell Lung Cancer

Secondary study objectives

Barriers to Sample Acquisition

Mutation Distribution

Rate of Asymptomatic or Mildly Symptomatic Lung Cancer

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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 cfDNA testing. If the investigational test is positive or indeterminant, these participants 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. Participants will be notified of results. Additionally, participants may participant in optional studies: 1) One-time survey regarding perception of lung cancer screening and cfDNA testing, 2) Virtual focus group, 3) Blood banking study

0 / 5Eligibility criteria met