Evaluation of chronic pancreatitis for epidemiologic and translational studies

Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies - PROCEED Study

This study is trying to learn more about what causes chronic pancreatitis and how it gets worse over time by collecting information from patients across the U.S.

Quick facts

• Study type: Observational
• Enrollment: 2345 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (Academic / other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT03099850 on ClinicalTrials.gov

What this trial studies

This study aims to prospectively evaluate chronic pancreatitis to understand the factors contributing to its onset and progression. The Coordinating and Data Management Center at MD Anderson Cancer Center will oversee data management and coordination, while patient recruitment will occur at various external clinical centers across the U.S. The study is part of a larger NIH-funded consortium focused on chronic pancreatitis, diabetes, and pancreatic cancer. It will utilize comprehensive data management systems to ensure regulatory compliance and protocol monitoring.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals diagnosed with chronic pancreatitis.

Not a fit: Patients with autoimmune or traumatic pancreatitis, pancreatic tumors, or significant comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of chronic pancreatitis, potentially enhancing patient outcomes.

How similar studies have performed: Other studies have shown success in understanding chronic pancreatitis, but this specific approach is novel in its comprehensive longitudinal evaluation.

Eligibility criteria

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).

Where this trial is running

Houston, Texas

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Li Liang, PHD — M.D. Anderson Cancer Center
• Study coordinator: Li Liang, PHD

Conditions Pancreatitis; Chronic Pancreatitis; Data management; Regulatory compliance; Protocol monitoring