Clinical trial NCT03099850: Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies
Official title: Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies - PROCEED Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pancreatitis
Keywords: Chronic Pancreatitis
Data management
Regulatory compliance
Protocol monitoring
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
name: University of Minnesota
name: Ohio State University
name: Baylor College of Medicine
name: Indiana University
name: University of Florida
name: Cedars-Sinai Medical Center
name: Stanford University
name: Mayo Clinic
name: University of Pittsburgh Medical Center
name: Kaiser Permanente
First posted: 2017-04-04
Enrollment: 2345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants recruited from external sites.

Brief summary: 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".


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).

Primary outcomes:
measure: Safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
timeFrame: Through study completion; an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Li Liang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yadav D, Askew RL, Palermo T, Li L, Andersen DK, Chen M, Fisher WE, Fogel EL, Forsmark CE, Hart PA, Othman MO, Pandol SJ, Park WG, Topazian MD, Van Den Eeden SK, Vege SS, Yang Y, Serrano J, Conwell DL; Consortium for the Study of Chronic Pancreatitis, Diabetes; Pancreatic Cancer (CPDPC). Association of Chronic Pancreatitis Pain Features With Physical, Mental, and Social Health. Clin Gastroenterol Hepatol. 2023 Jul;21(7):1781-1791.e4. doi: 10.1016/j.cgh.2022.09.026. Epub 2022 Oct 1.
citation: Hart PA, Yadav D, Li L, Appana S, Fisher W, Fogel E, Forsmark CE, Park WG, Pandol S, Topazian MD, Van Den Eden SK, Vege SS, Bradley D, Serrano J, Conwell DL; Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). High Prevalence of Osteopathy in Chronic Pancreatitis: A Cross-sectional Analysis From the PROCEED Study. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2005-2013. doi: 10.1016/j.cgh.2021.09.026. Epub 2021 Sep 24.