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Trial record 18 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Pancreatitis, Chronic"

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

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ClinicalTrials.gov Identifier: NCT03058926
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : January 24, 2018
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Chronic Pancreatitis Diabetes Pancreatic Cancer Other: Data Management and Monitoring

Study Type : Observational
Estimated Enrollment : 25000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer
Actual Study Start Date : January 19, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Chronic Pancreatitis 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.


Diabetes 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.


Pancreatic Cancer 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.





Primary Outcome Measures :
  1. Protocol and Regulatory Compliance for Consortium Studies for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC) [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Blood and urine examined for biomarker evaluation.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, 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:

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

Exclusion Criteria:


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): NCT03058926


Contacts
Contact: Ziding Feng, PHD 713-563-4276 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Ziding Feng, PHD M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03058926     History of Changes
Other Study ID Numbers: PA16-0439
1U01DK108328-01 ( U.S. NIH Grant/Contract )
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: January 24, 2018
Last Verified: January 2018

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
Diabetes
Pancreatic Cancer
Data Management
Protocol compliance
Regulatory compliance
Consortium studies

Additional relevant MeSH terms:
Pancreatitis, Chronic
Diabetes Mellitus
Pancreatic Neoplasms
Pancreatitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases