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Item The National Gene Vector Biorepository's Pharm/Tox Database(Elsevier, 2009-04-01) Cornetta, Kenneth; Matheson, Lorraine; Medical and Molecular Genetics, School of MedicineItem 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(Wolters Kluwer, 2018-11) Yadav, Dhiraj; Park, Walter G.; Fogel, Evan L.; Li, Liang; Chari, Suresh T.; Feng, Ziding; Fisher, William E.; Forsmark, Christopher E.; Jeon, Christie Y.; Habtezion, Aida; Hart, Phil A.; Hughes, Steven J.; Othman, Mohamed O.; Rinaudo, Jo Ann; Pandol, Stephen J.; Tirkes, Temel; Serrano, Jose; Srivastava, Sudhir; Van Den Eeden, Stephen K.; Whitcomb, David C.; Topazian, Mark; Conwell, Darwin L.; Medicine, School of MedicineProspective 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.Item Standard Operating Procedures for Biospecimen Collection, Processing, and Storage: From the Type 1 Diabetes in Acute Pancreatitis Consortium(Wolters Kluwer, 2022) Wasserfall, Clive; Dyer, Anne-Marie; Speake, Cate; Andersen, Dana K.; Baab, Kendall Thomas; Bellin, Melena D.; Broach, James R.; Campbell-Thompson, Martha; Chinchilli, Vernon M.; Lee, Peter J.; Park, Walter G.; Pratley, Richard E.; Saloman, Jami L.; Sims, Emily K.; Tang, Gong; Yadav, Dhiraj; Yazici, Cemal; Conwell, Darwin L.; Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC); Pediatrics, School of MedicineDifferences in methods for biospecimen collection, processing, and storage can yield considerable variability and error. Therefore, best practices for standard operating procedures are critical for successful discovery, development, and validation of disease biomarkers. Here, we describe standard operating procedures developed for biospecimen collection during the DREAM (Diabetes RElated to Acute pancreatitis and its Mechanisms) Study within the Type 1 Diabetes in Acute Pancreatitis Consortium (T1DAPC). Notably these protocols were developed using an integrative process based on prior consortium experience and with input from working groups with expertise in immunology, pancreatitis and diabetes. Publication and adoption consistent biospecimen protocols will inform future studies and allow for better comparisons across different metabolic research efforts.