PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 21-010061
About this study
The main objective of this study is to generate real-world evidence reflecting the experience of individuals with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP). Efforts will be directed toward understanding the unmet need and therapeutic burden to identify the most critical factors that influence treatment choices/prescribing patterns, quality of life, and healthcare utilization outcomes in standard of care for individuals with EPI due to CP.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- At least 18 years of age (or age of majority).
- Willing to provide consent to participate.
- Meet ONE (1) of the following at the time of enrollment:
- Diagnosis of chronic pancreatitis (CP);
- Diagnosis of recurrent acute pancreatitis (RAP).
- Suspected or confirmed diagnosis of EPI made by a healthcare provider.
- On PERT, either prior to the Enrollment Visit or newly prescribed at the time of the Enrollment Visit.
Exclusion Criteria:
- Currently participating in or planning to participate in a double-blind randomized trial and/or open-label Phase 3b/4 on CP or EPI.
- Diagnosed with any of the following conditions at the time of enrollment:
- Cystic fibrosis;
- Fibrosing colonopathy;
- A history of or current diagnosis of pancreatic cancer, main duct papillary mucinous neoplasms (IPMNs), and other pancreatic malignancies;
- Allergy to pork or other porcine pancreatic enzyme products (PEPs);
- Any condition that would, in the investigator’s opinion, limit the individual’s ability to complete the study.
Eligibility last updated 9/24/21. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Jane Diamond, APRN |
Closed for enrollment |
|
More information
Publications
Publications are currently not available