Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

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".

Conditions

• Pancreatitis

Interventions

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

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• National Institutes of Health (NIH)

  collaborator NIH

• University of Minnesota

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Indiana University

  collaborator OTHER

• University of Florida

  collaborator OTHER

• Cedars-Sinai Medical Center

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• University of Pittsburgh Medical Center

  collaborator OTHER

• Kaiser Permanente

  collaborator OTHER

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Li Liang, PHD · M.D. Anderson Cancer Center

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-02-28

Primary Completion

2030-06-30

Completion

2030-06-30

Countries

• United States

Study Locations