The PROCEED Study
Condition: Pancreatitis
Eligibility
Key Inclusion Criteria
- Must be between 18-75 years old at the time of enrollment
GREEN GROUP I: No Pancreas Disease Controls
- No personal history or symptoms of pancreatic disease
GREEN GROUP II: Chronic Upper Abdominal Pain of Suspected Pancreatic Origin
- Referred to a pancreas or GI clinic or admitted to the hospital for evaluation unexplained upper abdominal pain of at least 3 months in duration
YELLOW GROUP I: Indeterminate Chronic Pancreatitis (CP) with no history of Acute Pancreatitis
- Referred to a pancreas or GI clinic or admitted to the hospital for evaluation of unexplained upper abdominal pain of at least 3 months in duration
YELLOW GROUP II: Acute Pancreatitis (AP)
- History of 1 documented attack of AP in the preceding 18 months
YELLOW GROUP III: Recurrent Acute Pancreatitis (RAP)
- 2 or more documented attacks of AP separated by at least 1 month
RED GROUP: Definite Chronic Pancreatitis
- Presence of unequivocal (definite) CP and/or parenchymal and/or ductal calcifications
Key Exclusion Criteria
GREEN GROUP I
- History of bleeding disorders
- Treatment with anticoagulants or antiplatelet therapy other than aspirin
ALL OTHER GROUPS EXCEPT GREEN GROUP I
- History of autoimmune or traumatic pancreatitis, or acute necrotizing pancreatitis which results in suspected disconnected duct syndrome
- Primary pancreatic tumors, neuroendocrine tumors and other uncommon tumors
Full Study Name
CPDPC16-02: Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (The PROCEED Study) (IRB no. 48265)
Summary
The purpose of this study is to learn about chronic pancreatitis and discover new ways to detect, treat and help prevent the disease. The study aims to determine how the diagnosis can be made earlier, why and how the disease progresses, and what genetic factors may affect the chances of developing chronic pancreatitis. Researchers also aim to learn about the natural history of chronic pancreatitis (what happens over a long period of time).
Chronic pancreatitis occurs when the pancreas is affected by inflammation and scarring. Since treatment options for advanced (end-stage) chronic pancreatitis are limited, patients with early-stage chronic pancreatitis or those at high risk of developing chronic pancreatitis are ideally suited for interventions to prevent the development of end-stage pancreatitis and its associated complications. This study aims to provide the most accurate and reliable estimates to date on disease progression and clinical events involving chronic pancreatitis. Participants will be asked to complete questionnaires and provide specimen samples, among other study procedures. Additionally, the participant’s physician and research coordinator will complete a case report form about the participant’s pancreatic history, symptoms and treatment.
Principal Investigator
Stephen Pandol, MD
Contact
Emily Hautamaki
Phone: 310-423-0347
Email: emily.hautamaki@cshs.org