Signature Development and Validation Protocol for an Epigenetic Assay in Diagnosing Pancreatic Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Study participants will be selected from patients being cared for across the University of Maryland Medical System
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
450 Participants
are grouped into 3 trial groupsGroup A: Study Population 1
Group B: Study Population 2
Group C: Study Population 3
Trial outcomes
Primary outcomes
1
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 years2
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 years3
Technology validation
The investigators will validate identified blood-based circulating methylation signatures in patients at high risk for developing pancreatic cancer.
Time frame
5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Maryland, Baltimore
Lead sponsor
EPOCH Epigenetics, Inc
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: