Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

M.D. Anderson Cancer Center

Status: Enrolling

Conditions: Pancreatitis

Treatments: Other: Data Management and Monitoring

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT03099850

NCI-2021-00441 (Other Identifier)

PA17-0104 (2020-1058)

1U01DK108328-01 (U.S. NIH Grant/Contract)

2020-1058 (Other Identifier)

Details and patient eligibility

About

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) Study, which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). No patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC. The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC).

PROCEED is the first study in the USA that is carefully following participants to better understand factors that may be responsible for causing pancreatitis and how it progresses. The study is being conducted at the following 9 major clinical centers across the US:

• Baylor College of Medicine
• Cedars-Sinai Medical Center
• University of Florida
• Indiana University
• Mayo Clinic
• University of Minnesota
• Ohio State University
• Stanford University
• University of Pittsburgh

The study is enrolling participants who are at different stages of chronic pancreatitis, including those with no known pancreas disease (controls), and those with abdominal pain, one or more attacks of pancreatitis, or chronic pancreatitis. After enrollment, participants with abdominal pain and pancreatitis are asked to follow-up every year to learn about their symptoms and any changes in the disease. PROCEED investigators plan to use the detailed information they collect to better understand the disease and identify new treatments.

"More details and updated information about this study can be found at the study's public website: https://www.cpdpc-research-consortium.org/research- study-cpdpc-16-02-proceed".

Enrollment: 2,345 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Participants with chronic pancreatitis.

Exclusion criteria

ALL GROUPS EXCEPT GREEN GROUP I:

1. History of autoimmune or traumatic pancreatitis, or sentinel attack of acute necrotizing pancreatitis which results in suspected
2. Primary pancreatic tumors - pancreatic ductal adenocarcinoma, suspected cystic neoplasm (>1 cms in size or main duct involvement), neuroendocrine tumors, and other uncommon tumors.
3. Pancreatic metastasis from other malignancies.
4. History of solid organ transplant, HIV/AIDS.
5. Known isolated pancreatic exocrine insufficiency (e.g. in the absence of any eligible inclusion criteria).
6. Participants must not have medical or psychiatric illnesses or ongoing substance abuse that in the investigator's opinion would compromise their ability to tolerate study interventions or participate in longitudinal follow up.
7. Patients with known abnormal creatinine (GFR < 30) or renal failure (applies to patients with chronic upper abdominal pain of suspected pancreatic origin and suspected CP (Yellow) subgroups).
8. Failure to agree for longitudinal follow-up.
9. Known Pregnancy. All participants of childbearing potential, except if post-menopausal [i.e. no menses for ≥2 years] or had a hysterectomy, bilateral tubal ligation/clip (surgical sterilization) or surgical removal of both the ovaries), must have a negative urine or serum B-HCG pregnancy test documented within 2 days prior to any endoscopic or radiologic procedures done for research purposes. Any standard of care tests will follow institutional policies regarding pregnancy test.
10. Currently incarcerated.
11. Inability to get MRI/MRCP in patients with chronic abdominal pain of suspected pancreatic origin (Green II) or Suspected CP (Yellow groups) at baseline (e.g. metal object in the body which precludes performance of MRI).

Trial design

2,345 participants in 1 patient group

Observational cohort study of adult patients with suspected or definite CP

Description:

* Chronic Upper Abdominal Pain of Suspected Pancreatic Origin * Suspected Chronic Pancreatitis (Patients with Acute Pancreatitis, Recurrent Acute Pancreatitis, or Indeterminate CP without prior AP) * Definite Chronic Pancreatitis * Chronic Abdominal Pain- Undifferentiated Group

Treatment:

Other: Data Management and Monitoring