Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

Launched by M.D. ANDERSON CANCER CENTER · Mar 28, 2017

Keywords

ClinConnect Summary

The Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCCEED) is a research study that aims to learn more about chronic pancreatitis, a condition that causes inflammation of the pancreas. This study is part of a larger effort funded by the National Institutes of Health to understand the connections between chronic pancreatitis, diabetes, and pancreatic cancer. While MD Anderson Cancer Center is managing the study, they will not be enrolling patients directly. Instead, patients will be recruited from other participating sites.

To join the study, participants need to have a diagnosis of chronic pancreatitis. There are no specific exclusions mentioned, so if you meet the criteria, you might be eligible. While the study is currently active, it is not recruiting new participants at this time. Those involved can expect their data to be managed carefully as part of a comprehensive research effort aimed at improving understanding and treatment of chronic pancreatitis and related conditions.

Gender

ALL

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).