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

University of Maryland Baltimore (UMB)

Status: Enrolling

Conditions: Lung Cancer Screening; Lung Cancer; Healthy Volunteers (HV); Unhealthy Volunteers

Treatments: Other: Epigenetic Signature Assay

Study type: Observational

Funder types: Other

Identifiers

NCT07008664

HP-00110218

Details and patient eligibility

About

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.

Full description

This clinical testing research study outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host DNA methylation signatures designed to diagnose lung cancer. The overall protocol process will involve three distinct stages representing three patient cohorts with up to 250 subjects per cohort across 5 populations of patients. Cohort one will act as signature development phase; cohort two will act as signature finalization phase; and cohort three will act as a validation cohort phase. Each cohort will include the following patient populations with up to 50 patients per population:

1. Lung cancer; No chemotherapy. Surgical resection or stereotactic body radiation therapy (SBRT) only
2. Lung cancer; With chemotherapy. All stages including remission
3. At risk group (Lung cancer screening population)
4. Control group with mixed comorbid disease EXCLUDING tobacco use of greater than 10 pack years (PY) or chronic obstructive pulmonary disease (COPD)
5. Healthy controls with no comorbid disease

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

750 participants in 5 patient groups

Study Population 1

Description:

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.

Treatment:

Other: Epigenetic Signature Assay

Study Population 2

Description:

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.

Treatment:

Other: Epigenetic Signature Assay

Study Population 3

Description:

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.

Treatment:

Other: Epigenetic Signature Assay

Study Population 4

Description:

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.

Treatment:

Other: Epigenetic Signature Assay

Study Population 5

Description:

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

Treatment:

Other: Epigenetic Signature Assay