RecruitingNCT07008664

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

Sponsor

University of Maryland, Baltimore

Enrollment

750 participants

Start Date

Mar 31, 2025

Study Type

OBSERVATIONAL

Conditions

Lung Cancer Lung Cancer Screening Healthy Volunteers (HV)Unhealthy Volunteers

Summary

The purpose of this research study is to test a new process for diagnosing lung cancer by examining changes to your DNA that can be detected from a blood test. The information we learn by doing this study could potentially help people in the future. Participants in this study will have blood samples collected, have their medical records reviewed by study personnel and fill out questionnaires at different time points during the study. Blood sample collection will occur during normal routine clinic visits. Participation in this study will last approximately 5 years.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is developing and validating a blood-based test that uses epigenetics — chemical changes in DNA that affect how genes are read — to detect lung cancer. Current lung cancer diagnosis often requires invasive biopsies or advanced imaging. This test aims to identify lung cancer earlier and less invasively by analyzing patterns in a blood sample, which could improve outcomes for patients. **You may be eligible if...** - You are 18 years or older - You are a patient receiving care at the University of Maryland Baltimore Washington Medical Center - You are willing and able to consent to the study's blood collection procedures - You can communicate in English **You may NOT be eligible if...** - You are under 18 years old - You are not a patient at the University of Maryland Baltimore Washington Medical Center - You are unable to provide informed consent - You cannot speak or understand English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEREpigenetic Signature Assay

Up to 15 ml of blood will be collected from each patient at various time points throughout their 5 years of participation. DNA extraction, bisulfite conversion and analysis of epigenetic markers through PCR or next-generation sequencing will be performed. An epigenetic signature assay will then be identified.