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Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03099850
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : May 5, 2022
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

Study Description
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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 Design
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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 : December 31, 2022
Estimated Study Completion Date : June 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Groups and Cohorts
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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.


Outcome Measures
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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 ]

Eligibility Criteria
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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:

N/A

Contacts and Locations
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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
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Contact: Li Liang, PHD 713-563-4276 lli15@mdanderson.org

Locations
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United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77339
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Li Liang, PHD M.D. Anderson Cancer Center
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03099850    
Obsolete Identifiers: NCT04753255
Other Study ID Numbers: PA17-0104 (2020-1058)
1U01DK108328-01 ( U.S. NIH Grant/Contract )
2020-1058 ( Other Identifier: MD Anderson Cancer Center )
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: May 5, 2022
Last Verified: May 2022

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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:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases