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New blood test aims to catch lung cancer early in underserved groups

NCT ID NCT06716580

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This study is testing a new blood test that looks for pieces of tumor DNA (EGFR mutations) to screen for lung cancer in healthy people aged 50-80 who are of East Asian, Southeast Asian, or Hispanic/Latinx background and do not currently smoke. The goal is to find lung cancer early in those who cannot get regular CT scans. The test is not yet proven, and positive results will be double-checked with standard methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood test (ctDNA assay)
What this could lead to
If successful, this blood test could provide a simple, accessible way to catch EGFR-positive lung cancer early in high-risk groups who are not eligible for standard screening.
What could go wrong
This is an early-stage screening study, not a treatment trial. The test may produce false positives or negatives, and it only detects certain EGFR mutations, missing other lung cancers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • Dana-Farber Cancer Institute South Shore

    NOT_YET_RECRUITING

    South Weymouth, Massachusetts, 02190, United States

  • Dana-Farber Cancer Institute at Steward St. Elizabeth's

    NOT_YET_RECRUITING

    Brighton, Massachusetts, 02135, United States

  • Dana-Farber Cancer Instiute Merrimack Valley

    NOT_YET_RECRUITING

    Methuen, Massachusetts, 01844, United States

  • Massachusetts General Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02215, United States

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