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Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

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ClinicalTrials.gov Identifier: NCT03099850
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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).

Condition or disease Intervention/treatment
Pancreatitis Other: Data Management and Monitoring

Study Type : Observational
Estimated Enrollment : 999 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies - PROCEED Study
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Group/Cohort Intervention/treatment
Chronic Pancreatitis 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.




Primary Outcome Measures :
  1. Compliance Monitoring of Regulatory Documents by the Statistician for Consortium Study of Chronic Pancreatitis by CDMC by Implementing Quality Assurance and Quality Control Systems to Ensure Quality Data and Protocol Compliance [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants recruited from external sites.
Criteria

Inclusion Criteria:

1. Participants with chronic pancreatitis.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099850


Contacts
Contact: Ziding Feng, PHD 713-563-4276 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77339
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ziding Feng, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03099850     History of Changes
Other Study ID Numbers: PA17-0104
1U01DK108328-01 ( U.S. NIH Grant/Contract )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Chronic Pancreatitis
Data management
Regulatory compliance
Protocol monitoring

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases