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

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

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.

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

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