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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03058926
• Other study ID #: PA16-0439
• Secondary ID: 1U01DK108328-01
• Status: Recruiting
• Start date: January 19, 2017
• Est. completion date: January 2020

Study information

• Verified date: January 2019
• Source: M.D. Anderson Cancer Center
• Contact: Ying Yuan, PHD
• Phone: 713-563-4276
• Email: yyuan[@]mdanderson.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25000
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Diabetes
• Diabetes Mellitus
• Pancreatic Cancer
• Pancreatic Neoplasms
• Pancreatitis
• Pancreatitis, Chronic

Intervention

Other:
• Data Management and Monitoring
Clinical Research Support Center's Data Management and Multicenter Study Support (MCSS) teams responsible for monitoring protocol and regulatory compliance for all consortium studies. MCSS responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (4)

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

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   University of Texas MD Anderson Cancer Center Website