Recruiting

Genetic Testing

Sponsor:

University of Maryland, Baltimore

Code:

NCT07008664

Conditions

Lung Cancer

Lung Cancer Screening

Healthy Volunteers (HV)

Unhealthy Volunteers

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Epigenetic Signature Assay

Study Details

Brief 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.

Conditions

Lung Cancer

Lung Cancer Screening

Healthy Volunteers (HV)

Unhealthy Volunteers

Study ID

NCT07008664

Start date

Mar 31, 2025

Status verified date

Jul, 2026

Completion date

Apr, 2032

Anticipated

Primary completion date

Apr, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

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.

Study Population 5

This study population will consist of individuals who have no other significant medical problems.

Interventions

Epigenetic 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.

Primary outcome measure

  • Identification of tumor-associated host methylation signature [ Time Frame: 5 years ]
  • Technology development [ Time Frame: 5 years ]
  • Technology validation [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

McKenzie Bedra, MPH

410-553-8184McKenzie.Bedra@umm.edu

Jennifer Emel, MA

410-553-8048Jennifer.Emel@umm.edu

Locations

University of Maryland Baltimore Washington Medical Center

Recruiting

Glen Burnie, Maryland, United States, 21061

Contacts

Jeffrey Marshall, MD

410-787-4000Jeffrey.Marshall@umm.edu

Principal Investigator:

Jeffrey Marshall, MD

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • Lung Cancer
  • Lung Cancer Screening
  • Healthy Volunteers
  • Unhealthy Volunteers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2026-07-29.