Clinical trial NCT05762445: PAtient-CenTric Chronic Pancreatitis Registry (PACT-CP)
Official title: A Patient-Driven Registry for Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pancreatitis
Lead sponsor: CorEvitas
Sponsor class: NETWORK
Collaborators: name: Nestle Health Science
First posted: 2023-03-09
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective, non-interventional study for individuals with EPI due to CP who are under the care of a gastroenterologist.

Brief summary: 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.

Detailed description: Study participants will be followed prospectively, and data from study participants will be collected at 3-month intervals via Electronic Data Capture (EDC) portal. Investigators will complete assessments approximately every 6 months at the time of routine clinical encounters. Adverse Events (AEs) will be collected as part of the study data collection forms. Serious Adverse Events (SAEs) are to be reported within 24 hours (1 business day) of awareness, whether or not the site learns of the event at the time of a registry follow-up visit.

Eligibility criteria: Inclusion Criteria:

To be eligible for enrollment, a study participant must meet the inclusion criteria below:

1. At least 18 years of age (or age of majority)
2. Willing to provide consent to participate
3. Meet one (1) of the following at the time of enrollment:

   1. Diagnosis of chronic pancreatitis (CP)
   2. Diagnosis of recurrent acute pancreatitis (RAP)
4. Suspected or confirmed diagnosis of EPI made by a healthcare provider
5. On Pancreatic Enzyme Replacement Therapy (PERT), either prior to the Enrollment Visit or newly prescribed at the time of the Enrollment Visit.

To be eligible for enrollment into the registry, a study participant must not have any of the criteria below:

1. Currently participating in or planning to participate in a double-blind randomized trial and/or open-label Phase 3b/4 on CP or EPI
2. Diagnosed with any of the following conditions at the time of enrollment:

   1. Cystic fibrosis
   2. Fibrosing colonopathy
   3. A history of or current diagnosis of pancreatic cancer, main duct papillary mucinous neoplasms (IPMNs), and other pancreatic malignancies
   4. Allergy to pork or other porcine pancreatic enzyme products (PEPs)
   5. Any condition that would, in the investigator's opinion, limit the individual's ability to complete the study.

      -

      Exclusion Criteria:

      -

Primary outcomes:
measure: Main Objective of the Study
timeFrame: Up to 5 years
measure: Creation of a Patient Cohort
timeFrame: Up to 5 years
measure: Disease History and Progression Data at Initial Visit
timeFrame: At Initial Visit
measure: Progression Data (Every 3 months after Initial Visit)
timeFrame: Every 3 months after Initial Visit up to 5 years
measure: Progression Data (Every 6 months after Initial Visit)
timeFrame: Every 6 months after Initial Visit up to 5 years
measure: Clinical Care Practice Data at Initial Visit
timeFrame: At Initial Visit
measure: Clinical Care Practice Data (Every 3 months after Initial Visit)
timeFrame: Every 3 months after Initial Visit up to 5 years
measure: Clinical Care Practice Data (Every 6 months after Initial Visit)
timeFrame: Every 6 months after Initial Visit up to 5 years
measure: Treatment Compliance Data at Initial Visit
timeFrame: At Initial Visit
measure: Treatment Compliance Data (Every 3 months after Initial Visit)
timeFrame: Every 3 months after Initial Visit up to 5 years
measure: Treatment Compliance Data (Every 6 months after Initial Visit)
timeFrame: Every 6 months after Initial Visit up to 5 years
measure: Baseline Data
timeFrame: At Initial Visit
measure: PRO Data
timeFrame: Every 3 months after Initial Visit up to 5 years
measure: Impact and Burden of EPI due to CP Data at Initial Visit
timeFrame: At Initial Visit
measure: Impact and Burden of EPI due to CP (Every 3 months after Initial Visit)
timeFrame: Every 3 months after Initial Visit up to 5 years
measure: Impact and Burden of EPI due to CP (Every 6 months after Initial Visit)
timeFrame: Every 6 months after Initial Visit up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Waltham
country: United States
facility: CorEvitas
state: Massachusetts
Study officials:
affiliation: Director, University of Pittsburgh Medical Center
name: David Whitcomb, MD, PhD
role: STUDY_CHAIR
affiliation: University of Miami, Division of Gastroenterology
name: Jodie Barkin, MD
role: STUDY_CHAIR
affiliation: Mercy Clinic Gastroenterology
name: Samer Al-Kaade, MD
role: STUDY_CHAIR
affiliation: Harvard School of Medicine, Division of Gastroenterology and Hepatology
name: Yasmin Hernandez-Barco, MD
role: STUDY_CHAIR
affiliation: Mayo Clinic College of Medicine and Science
name: Rahul Pannala, MD
role: STUDY_CHAIR
References: