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NCT03099850 Clinical Trial

Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

Pancreatitis Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT03099850
Other study ID # PA17-0104 (2020-1058)
Secondary ID 1U01DK108328-012
Status Withdrawn
Phase
First received
Last updated
Start date March 15, 2017
Est. completion date July 30, 2021

Study information
Verified date May 2024
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).

Other known NCT identifiers
  • NCT04753255

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 30, 2021
Est. primary completion date July 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Participants with chronic pancreatitis. Exclusion Criteria: N/A

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Outcome
Type Measure Description Time frame Safety issue
Primary 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 5 years
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