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

Part of paid clinical trials in Glen Burnie, Maryland.

Sponsor
University of Maryland, Baltimore
Study ID
NCT07008664
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Epigenetic Signature Assay — OTHER
    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.

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Jun 2025
Primary completion
Apr 30, 2031
Completion
Apr 30, 2032

Study Design

Enrollment
750 participants (estimated)

Arms

  • Arm: Study Population 1
    This study population will consist of individuals who have a new diagnosis of lung cancer and have not received chemotherapy treatment for their lung cancer. Individuals who have received surgical resection or stereotactic body radiation therapy (SBRT) for their lung cancer will be included.
  • Arm: Study Population 2
    This study population will consist of individuals who have a diagnosis of lung cancer and have received chemotherapy treatment for their lung cancer. All stages of lung cancer will be included including individuals in remission.
  • Arm: Study Population 3
    This study population will consist of individuals who are at high risk of developing lung cancer, such as people with a long smoking history, and are receiving yearly lung screening scans.
  • Arm: Study Population 4
    This study population will consist of individuals who may be hospitalized for another condition such as pneumonia or heart failure at time of enrollment into the study. Individuals who have a greater than 10 pack year history of smoking will not be included in this population.
  • Arm: Study Population 5
    This study population will consist of individuals who have no other significant medical problems.

Primary Outcome Measure

Identification of tumor-associated host methylation signature [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Maryland Baltimore Washington Medical CenterGlen BurnieMaryland21061
Jeffrey Marshall, MD
[email protected]
410-787-4000
Jeffrey Marshall, MD (PRINCIPAL_INVESTIGATOR)
Peter Olivieri, MD (SUB_INVESTIGATOR)
Darwin Ashbaker, MD (SUB_INVESTIGATOR)

Find similar trials in Glen Burnie, MD

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of Maryland Baltimore Washington Medical Center· Glen Burnie, MD

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