New blood test aims to catch lung cancer early in underserved groups
NCT ID NCT06716580
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 Hide 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for EGFR gene mutation are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
6 sites. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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_RECRUITINGBoston, Massachusetts, 02215, United States
-
Dana-Farber Cancer Institute
RECRUITINGBoston, Massachusetts, 02215, United States
-
Dana-Farber Cancer Institute South Shore
NOT_YET_RECRUITINGSouth Weymouth, Massachusetts, 02190, United States
-
Dana-Farber Cancer Institute at Steward St. Elizabeth's
NOT_YET_RECRUITINGBrighton, Massachusetts, 02135, United States
-
Dana-Farber Cancer Instiute Merrimack Valley
NOT_YET_RECRUITINGMethuen, Massachusetts, 01844, United States
-
Massachusetts General Hospital
NOT_YET_RECRUITINGBoston, Massachusetts, 02215, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Surgeons could freeze lung tumors from miles away using 5G robots
- Can AI make lung cancer scans easier to read?
- Two-Drug combo targets Treatment-Resistant lung cancer
- Can an Anti-Fibrotic drug shield lungs from radiation after immunotherapy?
- App aims to catch a hidden radiotherapy side effect
- Which nerve block wins for lung surgery pain?