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Standard Operating Procedures for Biospecimen Collection, Processing, and Storage

From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer

Fisher, William E., MD, FACS*; Cruz-Monserrate, Zobeida, PhD; McElhany, Amy L., MPH*; Lesinski, Gregory B., PhD; Hart, Phil A., MD; Ghosh, Ria, MBA, MPH§; Van Buren, George, MD*; Fishman, Douglas S., MD; Rinaudo, Jo Ann S., PhD; Serrano, Jose, MD, PhD#; Srivastava, Sudhir, PhD; Mace, Thomas, PhD; Topazian, Mark, MD**; Feng, Ziding, PhD§; Yadav, Dhiraj, MD††; Pandol, Stephen J., MD‡‡; Hughes, Steven J., MD§§; Liu, Robert Y., MS∥∥; Lu, Emily, MS∥∥; Orr, Robert, BS¶¶; Whitcomb, David C., MD, PhD**; Abouhamze, Amer S., MHA##; Steen, Hanno, PhD***; Sellers, Zachary M., MD, PhD†††; Troendle, David M., MD‡‡‡; Uc, Aliye, MD§§§; Lowe, Mark E., MD, PhD∥∥∥; Conwell, Darwin L., MD on behalf of the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)

doi: 10.1097/MPA.0000000000001171
CPDPC Conference Reports

High-quality and well-annotated biorepositories are needed to better understand the pathophysiology and biologic mechanisms of chronic pancreatitis (CP) and its consequences. We report a methodology for the development of a robust standard operating procedure (SOP) for a biorepository based on the experience of the clinical centers within the consortium to study Chronic Pancreatitis, Diabetes and Pancreas Cancer Clinical Centers (CPDPC), supported by the National Cancer Institute and the National Institute for Diabetes and Digestive and Kidney Diseases as a unique multidisciplinary model to study CP, diabetes, and pancreatic cancer in both children and adults. Standard operating procedures from the CPDPC centers were evaluated and consolidated. The literature was reviewed for standard biorepository operating procedures that facilitated downstream molecular analysis. The existing literature on biobanking practices was harmonized with the SOPs from the clinical centers to produce a biorepository for pancreatic research. This article reports the methods and basic principles behind the creation of SOPs to develop a biorepository for the CPDPC. These will serve as a guide for investigators developing biorepositories in pancreas research. Rigorous and meticulous adherence to standardized biospecimen collection will facilitate investigations to better understand the pathophysiology and biologic mechanisms of CP, diabetes, and pancreatic cancer.

From the *The Elkins Pancreas Center, Michael E. DeBakey Department of Surgery, and Dan L. Duncan Cancer Center, Baylor College of Medicine, Houston, TX;

Division of Gastroenterology, Hepatology, and Nutrition, Department of Medicine, and Comprehensive Cancer Center, The Ohio State University Wexner Medical Center, Columbus, OH;

Winship Cancer Institute, Department of Hematology and Medical Oncology, Emory University, Atlanta, GA;

§Department of Biostatistics, The University of Texas MD Anderson Cancer Center; and

Department of Pediatrics, Baylor College of Medicine, Houston, TX;

Cancer Biomarkers Research Group, Division of Cancer Prevention, National Cancer Institute, Rockville; and

#Division of Digestive Diseases and Nutrition, National Institutes of Diabetes and Digestive and Kidney Diseases, Bethesda, MD;

**Department of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN;

††Division of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Pittsburgh, Pittsburgh, PA;

‡‡Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, CA;

§§Department of Surgery, University of Florida College of Medicine, Gainesville, FL;

∥∥Clinical Research Support Center, The University of Texas MD Anderson Cancer Center, Houston, TX;

¶¶Indiana Clinical and Translational Sciences Institute, Specimen Storage Facility, Indianapolis, IN;

##Clinical and Translational Sciences, University of Florida, Gainesville, FL;

***Departments of Pathology, Boston Children's Hospital and Harvard Medical School, Boston, MA;

†††Department of Pediatric Gastroenterology, Hepatology, and Nutrition, Lucile Packard Children's Hospital and Stanford University School of Medicine, Stanford, CA;

‡‡‡Department of Pediatrics, University of Texas Southwestern Medical School, Dallas, TX;

§§§Stead Family Department of Pediatrics, University of Iowa, Stead Family Children's Hospital, Iowa City, IA; and

∥∥∥Department of Pediatrics, Washington University School of Medicine, St Louis, MO.

Received for publication July 20, 2018; accepted August 24, 2018.

Address correspondence to: William E. Fisher, MD, FACS, Michael E. DeBakey Department of Surgery, Baylor College of Medicine, 6620 Main St, Suite 1425, Houston, TX 77030 (e-mail: wfisher@bcm.edu).

Research reported in this publication was supported by the National Cancer Institute and National Institute of Diabetes and Digestive and Kidney Diseases under award numbers U01DK108326 (Baylor College of Medicine), U01DK108327 (Ohio State University), U01DK108328 (University of Texas MD Anderson Cancer Center), U01DK108288 (Mayo Clinic), U01DK108306 (University of Pittsburgh), U01DK108314 (Cedars-Sinai Medical Center), U01DK108320 (University Of Florida), U01DK108323 (Indiana University), U01DK108300 (Stanford University), and U01 DK108334 (University of Iowa). The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

D.C.W. is a consultant for AbbVie, Regeneron, and Ariel Precision Medicine and may have equity in Ariel Precision Medicine. M.E.L. is on the Board of Directors of the National Pancreas Association and receives royalties from Millipore Inc and UpToDate. A.U. is a member of American Board of Pediatrics, Subboard of Pediatric Gastroenterology. The other authors declare no conflict of interest.

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