About this trial
The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) Study, which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). No patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC. The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC).
PROCEED is the first study in the USA that is carefully following participants to better understand factors that may be responsible for causing pancreatitis and how it progresses. The study is being conducted at the following 9 major clinical centers across the US:
* Baylor College of Medicine * Cedars-Sinai Medical Center * University of Florida * Indiana University * Mayo Clinic * University of Minnesota * Ohio State University * Stanford University * University of Pittsburgh
The study is enrolling participants who are at different stages of chronic pancreatitis, including those with no known pancreas disease (controls), and those with abdominal pain, one or more attacks of pancreatitis, or chronic pancreatitis. After enrollment, participants with abdominal pain and pancreatitis are asked to follow-up every year to learn about their symptoms and any changes in the disease. PROCEED investigators plan to use the detailed information they collect to better understand the disease and identify new treatments.
"More details and updated information about this study can be found at the study's public website: https://www.cpdpc-research-consortium.org/research- study-cpdpc-16-02-proceed".
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected
Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
Pancreatic metastasis from other malignancies.
History of solid organ transplant, HIV/AIDS.
Trial population
Participants recruited from external sites.
Trial design
Cohort
Prospective
Treatments tested in this trial
Data Management and Monitoring
Other interventionThe Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center responsible for monitoring protocol and regulatory compliance for consortium. CDMC responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study. * Study participants will complete questionnaires at baseline and during yearly follow-up. In the event a participant does not complete all or part of the patient or coordinator questionnaire, the study coordinator will complete questions via medical record review (e.g., demographics and family history) or via a telephone interview. * Biospecimen collection: blood, urine, saliva, stool. Biospecimens will be collected and processed in accordance with the CPDPC specimen collection procedures. * EUS or EGD with pancreatic fluid collection * imaging studies performed at baseline and at follow-up. * IV contrast-enhanced MRI and MRCP with secretin * IV contrast-enhanced CT Scan abdomen
Treatment groups
Trial outcomes
Primary outcomes
Safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
National Institutes of Health (NIH)
Collaborator
University of Minnesota
Collaborator
Ohio State University
Collaborator
Baylor College of Medicine
Collaborator
Indiana University
Collaborator
University of Florida
Collaborator
Cedars-Sinai Medical Center
Collaborator
Stanford University
Collaborator
Mayo Clinic
Collaborator
University of Pittsburgh Medical Center
Collaborator
Kaiser Permanente
Collaborator