Epigenetic Assay for Lung Cancer Diagnosis

This study is testing a new way to diagnose lung cancer by looking for specific changes in your DNA, called epigenetic markers, using a blood test. Researchers will collect blood samples and review medical records over about five years to see if this "Epigenetic Signature Assay" can accurately identify lung cancer. The goal is to develop and confirm this new diagnostic tool. You might be able to join if you are 18 or older, a patient at University of Maryland Baltimore Washington Medical Center, and can speak and understand English. The study aims to enroll 750 participants, including people with lung cancer, those at risk, and healthy volunteers. The study's success will be measured by identifying a specific DNA signature related to tumors and developing and validating the technology over one to five years. The current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 750 participants across three cohorts, each with five different patient populations.
What's involved
You will have blood samples collected during routine clinic visits, your medical records reviewed, and fill out questionnaires at different times over approximately five years.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately five years, with primary endpoints measured at one and five years.

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NCT07008664

Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer

Recruiting
Not specifiedAges 18+Observational
University of Maryland, Baltimore
~750 participants
Updated 2026-07-29 on ClinicalTrials.gov
What's tested:Epigenetic Signature Assay

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of tumor-associated host methylation signature
Measured over 5 years
+2 more outcomes measured
Lung Cancer
Lung Cancer Screening
Healthy Volunteers (HV)
Unhealthy Volunteers
1 sites across 1 states
Maryland1

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Eligibility criteria

Inclusion

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

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
  • Identification of tumor-associated host methylation signature5 years

    Genome-wide methylation profile of whole blood from lung cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects.

  • Technology development5 years

    The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction.

  • Technology validation1 year

    The investigators will validate identified blood-based circulating methylation signatures in patients with undiagnosed pulmonary nodules.