CPDPC16-02/PROCEED

Participating Institutions

  • Baylor College of Medicine

    • William Fisher

  • Cedars-Sinai Medical Center

    • Stephen Pandol

  • Indiana University

    • Evan Fogel

  • Mayo Clinic

    • Santhi Vege

  • Stanford University

    • Walter Park

  • The Ohio State's Wexner Medical Center

    • Darwin Conwell

  • University of Florida

    • Chris Forsmark

  • University of Pittsburgh Medical Center

    • Dhiraj Yadav

  • University of Minnesota

    • Melena Bellin

Title

Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

Study Co-Chairs

Dr. Conwell, The Ohio State University Wexner Medical Center

Dr. Yadav, University of Pittsburgh Medical Center

Study Overview

• 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, 2019, nine clinical centers of the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer have enrolled nearly 1,000 participants into the study. 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.

Primary Objectives

• To establish a model longitudinal research cohort of adult patients for the study of CP and its complications

• To estimate the risk of progression from suspected to definite CP, and the risk of new-onset diabetes or exocrine insufficiency in definite CP, and study how the risks are influenced by patient characteristics and conditions

• To test the predictive capability of candidate biomarkers for diagnosis and prognosis of CP

• To develop a framework for conducting biomarker, genetic, and mechanistic studies using clinical information and the biorepository developed as part of the longitudinal research cohort

References

• Yadav D, Park WG, Fogel EL, Li L, Chari ST, Feng Z, Fisher WE, Forsmark CE, Jeon CY, Habtezion A, Hart PA, Hughes SJ, Othman MO, Rinaudo JAS, Pandol SJ, Tirkes T, Serrano J, Srivastava S, Van Den Eeden SK, Whitcomb DC, Topazian M, Conwell DL; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). 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, and Pancreatic Cancer. Pancreas. 2018 Nov/Dec;47(10):1229-1238. PubMed PMID: 30325862.