Health TrialsbyHealthPanel

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

ConditionsLung CancerEGFR Gene Mutation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorDana-Farber Cancer Institute

About 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 accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

1,000 Participants
are divided into 1 treatment group
Group A: ctDNA AssayExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Detection Rate of Non-Small Cell Lung Cancer

The proportion of participants with a positive assay result who are subsequently diagnosed with lung cancer through clinical pathology, among all participants tested with the assay.

Time frame
2 years

Secondary outcomes

1

Testing Turnaround Time

The duration from the time of blood draw to the release of the ctDNA testing results to the study team.

Time frame
Up to 2 years
2

Recruitment Acceptability

Determining proportion of screened patients who are eligible and who consent to the trial at each collaboration site

Time frame
Up to 2 years
3

Barriers to Sample Acquisition

Examining barriers impeding scale-up of sample collection, handling, and delivery

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Beth Israel Deaconess Medical Center

Collaborator

Boston Medical Center

Collaborator

Massachusetts General Hospital

Collaborator

Source ClinicalTrials.gov
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