Developing and validating a blood test that reads DNA methylation to diagnose lung cancer
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer
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 |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Glen Burnie, Maryland) |
| Trial ID | NCT07008664 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Glen Burnie, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.