A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort

Abbreviated Name
NOD
Lead Investigator
Chari, SureshThe University of Texas MD Anderson Cancer Center
Coordinating Investigator
Feng, Ziding Fred Hutchinson Cancer Center
Involved Investigators

Abstact

1.0   STUDY OBJECTIVES Primary hypothesis/objective: To prospectively assemble a cohort of patients ≥50 and ≤85 years of age with New-onset Hyperglycemia and Diabetes (NOD), called the NOD Cohort, in order to: i)   Estimate the probability of pancreatic ductal adenocarcinoma (PDAC) in the NOD Cohort, ii)   Establish a biobank of clinically annotated biospecimens including a reference set of biospecimens from predominantly pre-diagnostic PDAC and control new-onset Hyperglycemia and type 2 Diabetes Mellitus (DM) patients, iii)   Facilitate validation of emerging tests for identifying NOD patients at high risk for having PDAC using the reference set

Aims

3.1   Overview a)   Assemble the NOD Cohort (Figure 1) A prospective NOD Cohort of 10,000 enrolled, eligible patients will be assembled over the next 5 years, with each patient participating for up to 3 years from the date they meet criteria for new onset hyperglycemia and diabetes. Sites electronic medical record databases or other avenues for recruitment, such as physician and self-referral, will be utilized to identify patients meeting criteria for NOD (Table 1). b)   Develop a Biobank We will follow standardized protocols for collection of data and bio-specimen samples; increase access to data and sharing of data; improve quantity, quality, and continuum of all patient data and bio-specimens; and enhance recruitment processes for study enrollment. All patients in the NOD protocol will provide biospecimens at baseline (at the time of recruitment), and subsequently at 6, 12, and 24 months. Blood will be collected and kept for storage and future use. The approach is outlined in Figure 1. c)   Estimate the probability of PDAC in the prospectively assembled NOD Cohort The 1-year, 2-year, and 3-year incidence rates of PDAC and their 95% confidence intervals will be calculated via passive surveillance of health status of all enrolled patients (See Section 7). d)   Establish a specimen reference set to validate emerging tests for identifying NOD patients at high risk for having PDAC Future promising biomarkers for PDAC early detection, after the consortium review and approval, can be evaluated on this specimen reference set for its sensitivity, specificity, PPV, and NPV in predicting 1-year, 2-year, and 3-year PDAC risk. The intended future clinical application is to select NOD patients with high risk for PDAC for additional diagnostic work up.

Analytic Method

N/A analytic plan depends on applicant

Biomarkers

  • No biomarkers available at this time for this protocol

Data Collections

  • No data available at this time for this protocol
Protocol ID
434
Protocol Type
Reference Set
Field of Research
Other, Specify
Collaborative Group
G.I. and Other Associated Cancers Research Group
Cancer Types
  • Malignant neoplasm of pancreas

Associated Forms