PROspective Evaluation of Chronic Pancreatitis for EpidEmiologic and Translational StuDies: Rationale and Study Design for PROCEED From the Consortium for the Study of Chronic Pancreatitis, Diabetes,

Date:	November / December 2018
PMID:	30325862
Category:	1
Authors:	Dhiraj Yadav, Walter G Park 1, Evan L Fogel 2, Liang Li 3, Suresh T Chari 4, Ziding Feng 5, William E Fisher 6, Christopher E Forsmark 7, Christie Y Jeon 8, Aida Habtezion 1, Phil A Hart 9, Steven J Hughes 10, Mohamed O Othman 11, Jo Ann S Rinaudo 12, Stephen J Pandol 13, Temel Tirkes 14, Jose Serrano 15, Sudhir Srivastava 12, Stephen K Van Den Eeden 16, David C Whitcomb, Mark Topazian 4, Darwin L Conwell 9; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)
Abstract:

Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCEED) is the first prospective, observational cohort study of chronic pancreatitis (CP) in the United States. The primary goals of PROCEED are to define disease progression, test the predictive capability of candidate biomarkers, and develop a platform to conduct translational and mechanistic studies in CP. Using objective and consensus-driven criteria, PROCEED will enroll adults at different stages of CP-controls, suspected CP, and definite CP. In addition to collecting detailed information using structured case report forms and protocol-mandated evaluations at baseline and during follow-up, PROCEED will establish a linked biorepository of blood, urine, saliva, stool, pancreatic fluid, and pancreatic tissue. Enrollment for PROCEED began in June 2017. As of July 1, 2018, nine clinical centers of the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer are enrolling, and 350 subjects have completed baseline evaluation. In conclusion, PROCEED will provide the most accurate and reliable estimates to date on progression of CP. The established cohort and biorepository will facilitate numerous analyses, leading to new strategies for diagnosis, methods to monitor disease progression, and treatment of CP.

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Acknowledgements:

The content of this article is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute, the National Institute of Health, or the National Institute of Diabetes and Digestive and Kidney Diseases.

The Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) Research Consortia is supported and funded by grants from the National Cancer Institute and the National Institute of Diabetes and Digestive and Kidney Diseases under the following award numbers:

Project Number:	Awardee Organization
U01DK108326	Baylor College of Medicine
U01DK108314	Cedars-Sinai Medical Center
U01DK108332	Indiana University
U01DK108323	Kaiser Foundation Research Institute
U01DK108288	Mayo Clinic
U01DK108327	Ohio State University
U01DK108300	Stanford University
U01DK108320	University of Florida
U01DK108306	University of Pittsburgh
U01DK108328	University of Texas MD Anderson Cancer Center