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

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

Inclusion Criteria4

  • 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 Criteria4

  • 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

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.


Locations(1)

University of Maryland Baltimore Washington Medical Center

Glen Burnie, Maryland, United States

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NCT07008664


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