NCT03058926

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 19, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 15, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

January 14, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

February 15, 2017

Last Update Submit

January 11, 2019

Conditions

Chronic PancreatitisDiabetesPancreatic Cancer

Keywords

Chronic PancreatitisDiabetesPancreatic CancerData ManagementProtocol complianceRegulatory complianceConsortium studies

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Chronic Pancreatitis

Other: Data Management and Monitoring

Diabetes

Other: Data Management and Monitoring

Pancreatic Cancer

Other: Data Management and Monitoring

Interventions

Data Management and MonitoringOTHER

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.

Chronic PancreatitisDiabetesPancreatic Cancer

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants recruited from external sites.

You may qualify if:

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

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine examined for biomarker evaluation.

MeSH Terms

Conditions

Pancreatitis, ChronicDiabetes MellitusPancreatic Neoplasms

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland Neoplasms

Study Officials

  • Ying Yuan, PHD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Yuan, PHD

CONTACT

713-563-4276yyuan@mdanderson.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2017

First Posted

February 23, 2017

Study Start

January 19, 2017

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

January 14, 2019

Record last verified: 2019-01

Locations

US(1)