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

Brief summary public domain (ClinicalTrials.gov)

The purpose of this research study is to test a new process for diagnosing pancreatic 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.

Detailed description public domain (ClinicalTrials.gov)

This clinical testing protocol outlines the validation process for an epigenetic assay targeting host peripheral blood cell and the associated host DNA methylation signatures designed to diagnose pancreatic cancer. The overall protocol process will involve three distinct stages representing three patient cohorts with up to 150 subjects per cohort across 3 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 with include the following patient populations with up to 50 patients per population: 1. Pancreatic cancer, NO chemotherapy. Surgical resection and/or radiation therapy 2. Pancreatic cancer, WITH chemotherapy. All stages including remission 3. At risk group (individuals who have chronic pancreatitis, been diagnosed with an intraductal papillary mucinous neoplasm (IPMN), have a family history of pancreatic cancer and/or have a known genetic disposition)

Arm public domain (ClinicalTrials.gov)

Study Population 1 (): This study population will consist of individuals who have a diagnosis of pancreatic cancer and have not received chemotherapy treatment for their pancreatic cancer. Individuals who have received surgical resection and/or radiation therapy for their pancreatic cancer will be included.

Arm public domain (ClinicalTrials.gov)

Study Population 2 (): This study population will consist of individuals who have a diagnosis of pancreatic cancer and have received chemotherapy treatment for their pancreatic cancer. All stages of pancreatic cancer will be included including individuals in remission.

Arm public domain (ClinicalTrials.gov)

Study Population 3 (): This study population will consist of individuals who are at high risk of developing pancreatic cancer.

Primary outcome public domain (ClinicalTrials.gov)

Identification of tumor-associated host methylation signature. Genome-wide methylation profile of whole blood from pancreatic cancer patients, pre-cancer patients, patients undergoing therapy, and control subjects. Time frame: 5 years.

Primary outcome public domain (ClinicalTrials.gov)

Technology development. The investigators will develop array-based assays using whole-blood samples, focused on disease-specific methylation sites to provide early diagnosis, prognosis, and therapeutic efficacy prediction. Time frame: 5 years.

Primary outcome public domain (ClinicalTrials.gov)

Technology validation. The investigators will validate identified blood-based circulating methylation signatures in patients at high risk for developing pancreatic cancer. Time frame: 5 years.

Eligibility public domain (ClinicalTrials.gov)

Inclusion Criteria: * 18 years old or older * Patient of UMMS * Willing and able to consent to study procedures listed in the protocol * Ability to speak and understand English * Has a history of pancreatic cancer of is at high risk for pancreatic cancer Exclusion Criteria: * Younger than 18 years old * Patient not cared for at UMMS * Unable to consent to study procedures listed in the protocol * Unable to speak or understand English * Does not have a history of pancreatic cancer or is not at high risk for pancreatic cancer

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 450 participants (estimated).