Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer

• Conditions: Diabetes; Pancreatic Cancer; Chronic Pancreatitis
• Interventions: Other: Data Management and Monitoring

• Registration Number: NCT03058926
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

The data management systems, auditing, and monitoring effort are supported by the MD Anderson Cancer Center Clinical Research Support Center (CRSC). The The Coordination and Data Management Center (CDMC) will provide high quality, efficient and consistent leadership and services in all aspects of data quality and assurance; data harmonization and management; while providing assistance to the projects in disseminating and interpreting those data. The CDMC PI will provide statistical (study design, analysis plans, data analysis, and interpretation), data management, and data monitoring/auditing (data quality assurance and harmonization) expertise for the proposed projects. The Cancer Center will have access to identifiable data from studies; analysis of this data will not be conducted under this protocol. Any future analysis conducted on data or specimens as part of CPDPC protocols will be conducted under a separate IRB approved data or lab protocol.

The CDMC will leverage existing support, infrastructure, and resources from the Data Management and Coordinating Center for the Global Cancer Early Detection and the clinical expertise of the Division of Pathology/Lab Medicine at MDACC.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-19
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14
• Primary Completion: 2020-01
• Study Completion: 2020-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25000

Inclusion Criteria

• Participants with chronic pancreatis, diabetes, and pancreatic cancer recruited through Consortium.

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Chronic Pancreatitis	Data Management and Monitoring	-
Pancreatic Cancer	Data Management and Monitoring	-
Diabetes	Data Management and Monitoring	-

Primary Outcome Measures

Name	Time	Method
Protocol and Regulatory Compliance for Consortium Studies for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC)	3 years	Clinical Research Support Center's Data Management and Multicenter Study Support (MCSS) will monitor data quality and protocol compliance at all participating institutions.

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States