Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

October 10, 2025 updated by: M.D. Anderson Cancer Center

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

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".

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2345

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77339
        • Recruiting
        • University of Texas MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants recruited from external sites.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational cohort study of adult patients with suspected or definite CP
  • 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
Other: Data Management and Monitoring

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center responsible for monitoring protocol and regulatory compliance for consortium. CDMC responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study.

  • Study participants will complete questionnaires at baseline and during yearly follow-up. In the event a participant does not complete all or part of the patient or coordinator questionnaire, the study coordinator will complete questions via medical record review (e.g., demographics and family history) or via a telephone interview.
  • Biospecimen collection: blood, urine, saliva, stool. Biospecimens will be collected and processed in accordance with the CPDPC specimen collection procedures.
  • EUS or EGD with pancreatic fluid collection

  • imaging studies performed at baseline and at follow-up.

    • IV contrast-enhanced MRI and MRCP with secretin
    • IV contrast-enhanced CT Scan abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: Through study completion; an average of 1 year.
Through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

Mayo Clinic
Baylor College of Medicine
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
University of Florida
Stanford University
Ohio State University
University of Minnesota
Cedars-Sinai Medical Center
Indiana University
Kaiser Permanente
University of Pittsburgh Medical Center

Investigators

  • Principal Investigator: Li Liang, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2017

Primary Completion (Estimated)

June 30, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

March 15, 2017

First Submitted That Met QC Criteria

March 28, 2017

First Posted (Actual)

April 4, 2017

Study Record Updates

Last Update Posted (Estimated)

October 14, 2025

Last Update Submitted That Met QC Criteria

October 10, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA17-0104 (2020-1058)
  • 1U01DK108328-01 (U.S. NIH Grant/Contract)
  • 2020-1058 (Other Identifier: MD Anderson Cancer Center)
  • NCI-2021-00441 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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