Neoplasms

Symptoms and General Pathology

All Conditions

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Rare Diseases

Neoplasm Metastasis

Diabetes Mellitus

Pancreatic Neoplasms

Pancreatitis

Pancreatitis, Chronic

Metabolic Diseases

Glucose Metabolism Disorders

Endocrine System Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Chronic Disease

Disease Attributes

Pancreatic Cancer

Chronic Graft Versus Host Disease

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT).

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC).

Data Management and Monitoring

Ying Yuan, PHD

Suresh Chari, MBBS

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer will be responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC). Similar to all studies that will be coordinated and managed by the CDMC, no patient enrollment will occur at MDACC. All patient recruitment will occur at external sites that are a part of the CPDPC, which are listed in the appended DETECT protocol. The data management systems, auditing, and monitoring effort are supported by the CDMC.

Objectives:

1. Evaluate the pancreatic polypeptide response following a standardized mixed meal in new onset diabetes associated with PDAC (particularly with a proximal tumor) and chronic pancreatitis vs. T2DM.
2. Evaluate the insulin and glucagon response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
3. Evaluate the incretin response following a standardized mixed meal in new onset diabetes associated with PDAC and chronic pancreatitis vs. T2DM.
4. Explore the differences in analytes from Objectives 1-3 in a cohort of subjects with the same diseases and long-standing DM or normoglycemia.
5. Evaluate differences in fasting levels of insulin and novel biomarkers in pancreatic cancer compared to chronic pancreatitis and T2DM.
6. Explore the metabolic alterations (including pancreatic polypeptide response and insulin secretion) in diabetes associated with pancreatic surgery for chronic pancreatitis.

Blood samples collected at a fasting baseline (time 0 min), then 15, and 30 minutes following meal stimulation.

Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)

The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center will monitor protocol and regulatory compliance at all participating institutions.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

M.D. Anderson Cancer Center

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.

Clinical Research Operations

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.

Blood and urine examined for biomarker evaluation.

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

Clinical Research Support Center's Data Management and Multicenter Study Support (MCSS) will monitor data quality and protocol compliance at all participating institutions.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of a Mixed Meal Test for Diagnosis and Characterization and Type 3c Diabetes Mellitus Secondary to Pancreatic Cancer and Chronic Pancreatitis (DETECT)	NCT03460769	Pancreatic Canc... Chronic Pancrea... Diabetes Mellit...	Data Management...	30 Years - 84 Years	M.D. Anderson Cancer Center
Coordinating and Data Management Center for the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer	NCT03058926	Chronic Pancrea... Diabetes Pancreatic Canc...	Data Management...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for data management and monitoring