Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03058926

Conditions

Chronic Pancreatitis

Diabetes

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Data Management and Monitoring

Study Details

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.

Conditions

Chronic Pancreatitis

Diabetes

Pancreatic Cancer

Study ID

NCT03058926

Start date

Jan 19, 2017

Status verified date

Jan, 2019

Completion date

Jan, 2020

Anticipated

Primary completion date

Jan, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Study Design

Enrollment

25000 participants

Anticipated

Interventions and Outcome Measures

Arms

Chronic Pancreatitis

Diabetes

Pancreatic Cancer

Interventions

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.

Primary outcome measure

  • Protocol and Regulatory Compliance for Consortium Studies for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Locations

University of Texas MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Clinical Research Operations

yyuan@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Jan 14, 2019

Last verified

Jan, 2019

Keywords

  • Chronic Pancreatitis
  • Diabetes
  • Pancreatic Cancer
  • Data Management
  • Protocol compliance
  • Regulatory compliance
  • Consortium studies

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2019-01-14.