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.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Lung Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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Inclusion
Exclusion
What this trial measures
- 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.