The Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCEED) is an observational cohort study of adult participants with suspected or definite chronic pancreatitis (CP) that are prospectively ascertained and undergo yearly follow-up during clinical care. Participants complete study questionnaires, provide specimens, and consent for access to their protected health records at baseline and during follow-up for the duration of the study. Long term follow-up is needed to assess for progression to CP-related endpoints, pancreatic cancer, and overall survival. Participants of varying health status but without symptoms or diagnosis of pancreatic disease, or those with unexplained upper abdominal pain but no evidence of pancreatic disease, are classified as controls. Subsets of participants undergo laboratory tests, radiologic, or diagnostic endoscopic procedures for clinical or research purposes.

The primary objectives are to establish a longitudinal research cohort of adult participants 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; to develop a framework for conducting biomarker, genetic, and mechanistic studies using clinical information and specimens; and to test the predictive capability of candidate biomarkers for diagnosis and prognosis of CP.

The secondary objectives are to study clinical aspects of CP, associated complications, and determinants for participants with suspected and definite CP; and also assess biomarkers and mechanism of the disease through discovery, validation, and prognosis phases.

Outcome measures include progression from suspected CP to definite CP, development of new-onset diabetes, ability to differentiate chronic upper abdominal pain of suspected pancreatic origin, biomarker discovery and validation, diagnostic and prognostic biomarker development, clinical outcomes of CP (e.g., pain, exocrine insufficiency, metabolic bone disease, pancreatic cancer, quality of life, morphological evolution of disease, quantification of clinical events, mortality), microbiome investigation and discovery, and genetic markers of pancreatic disease.

• All participants must be ≥ 18 years old and ≤ 75 years at the time of enrollment
• Provide informed consent
• Meet one set of group-specific inclusion criteria for the control groups (Green Group I: No pancreas disease controls, or Green Group II: Chronic upper abdominal pain of suspected pancreatic origin), suspected CP groups (Yellow Group I: Indeterminate CP with no history of acute pancreatitis, Yellow Group II: Acute pancreatitis, or Yellow Group III: Recurrent acute pancreatitis), or the definite CP group (Red Group: Definite chronic pancreatitis); see the protocol for inclusion criteria per group

Exclusion criteria for all groups except Green Group I:

• History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected disconnected duct syndrome
• Primary pancreatic tumors such as pancreatic ductal adenocarcinoma, suspected cystic neoplasm (> 1 cm in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors
• Pancreatic metastasis from other malignancies
• History of solid organ transplant, HIV/AIDS
• Known isolated pancreatic exocrine insufficiency (e.g., in the absence of any eligible inclusion criteria)
• Medical or psychiatric illnesses or ongoing substance abuse that would compromise ability to tolerate study interventions or participate in longitudinal follow up
• Abnormal creatinine (GFR < 30) or renal failure
• Known pregnancy
• Currently incarcerated
• Inability to get MRI/MRCP

The study is ongoing. For ancillary study proposals, please reach out to DCC_Support@MDAnderson.org.