Developing and validating a blood test that reads DNA methylation to diagnose lung cancer
Official title: Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer
Run by University of Maryland, Baltimore · NCT07008664 · Data updated 2026-11-12
This project will test a blood test that looks at DNA changes to see if it can detect lung cancer in people being screened or treated.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 750 (estimated) |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Glen Burnie, Maryland) |
| Status | Recruiting |
| Started | March 31, 2025 |
| Main results expected | April 2031 |
| Study ends | April 2032 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07008664 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults (18+) receiving care at University of Maryland Baltimore Washington Medical Center who are diagnosed with lung cancer (with or without chemotherapy), are in a lung cancer screening population, or are eligible healthy or mixed-disease control volunteers willing to give blood and complete questionnaires.
✕Probably not a fit
People under 18, individuals not cared for at the study site, non-English speakers, or those expecting direct treatment benefit should not expect personal medical benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational project collects blood samples, medical record data, and questionnaires over about five years to develop and validate an epigenetic (DNA methylation) signature for lung cancer diagnosis. The work is organized into three sequential cohorts (development, finalization, and validation) with up to 250 subjects per cohort drawn from five population groups including lung cancer patients (with and without chemotherapy), an at-risk screening group, mixed-disease controls, and healthy controls. Blood draws occur during routine clinic visits and samples will be analyzed to identify and confirm methylation patterns that distinguish cancer from non-cancer. The final cohort is intended to validate the signature before broader clinical use.
Why it matters
Potential benefit: If successful, this test could allow earlier, less invasive detection of lung cancer from a simple blood draw, potentially improving diagnosis and treatment decisions.
How similar studies have gone: Previous research has shown promise for DNA methylation blood tests in detecting cancers and there are preliminary positive signals for lung cancer, but larger validation efforts are still needed.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years old or older * Patient at University of Maryland Baltimore Washington Medical Center * Willing and able to consent to study procedures listed in the protocol * Ability to speak and understand English Exclusion Criteria: * Younger than 18 years old * Patient not cared for at University of Maryland Baltimore Washington Medical Center * Unable to consent to study procedures listed in the protocol * Unable to speak or understand English
Where it's running
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University of Maryland Baltimore Washington Medical Center
Glen Burnie, Maryland, United States Recruiting
Study contacts
- Study coordinator: McKenzie Bedra, MPH
- Email: McKenzie.Bedra@umm.edu
- Phone: 410-553-8184
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.