CPDPC16-01/NOD

Participating Institutions

  • Advent Health Translational Research Institute

    • Anna Casu

  • Baylor College of Medicine

    • William Fisher

  • Carle Cancer Center

    • Kendrith Rowland Jr.

  • Cedars Sinai Medical Center

    • Stephen Pandol

  • Fred Hutchinson Cancer Research Center

    • Anirban MaitraZiding Feng

  • Henry Ford Health System

    • David Kwon

  • Indiana University Health

    • Kieren MatherZeb Saeed

  • Kaiser Permanente Northern California

    • Stephen Van den Eeden

  • Kaiser Permanente Southern California

    • Bechien Wu

  • Marshfield Clinic Health System

    • Adedayo Onitilo

  • Mayo Clinic

    • Suresh ChariGloria Petersen

  • Ochsner Medical Center

    • John Cole

  • Ohio State University Wexner Medical Center

    • David Bradley

  • Spartanburg Regional Health Services (Gibbs Cancer Center)

    • Amarinthia Curtis

  • Stanford University Medical Center

    • Walter Park

  • St. Joseph Mercy Health System

    • Tareq Al BaghdadiStella Philip

  • University of Florida

    • Steven Hughes

  • University of Pittsburgh Medical Center

    • Randall Brand

  • University of Southern California

    • James Buxbaum

  • VA Greater Los Angeles Healthcare System

    • Joseph Pisegna

Title

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


Study Co-Chairs
•    Dr. Anirban Maitra, University of Texas MD Anderson Cancer Center
•    Dr. Suresh Chari, University of Texas MD Anderson Cancer Center
•    Dr. Bechien Wu, Kaiser Permanente Southern California


Study Overview
"To prospectively assemble a cohort of subjects >50 and ≤85 years of age with New-onset Hyperglycemia and Diabetes (NOD), called the NOD Cohort, in order to:
1.    Estimate the probability of pancreatic ductal adenocarcinoma (PDAC) in the NOD Cohort,
2.    Establish a biobank of clinically annotated biospecimens including a reference set of biospecimens from pre-symptomatic PDAC and control new-onset hyperglycemia and type 2 diabetes mellitus (DM) subjects,
3.    Facilitate validation of emerging tests for identifying NOD subjects at high risk for having PDAC using the reference set.


Primary Objectives
1. Assemble the NOD Cohort
      1. A prospective NOD Cohort of 10,000 enrolled, eligible subjects will be assembled over the next 3 years, with each patient participating for up to 3 years from the date they meet criteria for hyperglycemia and diabetes.
2. Develop a Biobank
    1. All subjects in the NOD protocol will provide biospecimens at baseline (at the time of recruitment), and subsequently at 6, 12, and 24 months.
3.  Estimate the probability of PDAC in the prospectively assembled NOD Co-hort
    1. 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.
4.  Establish a specimen reference set to validate emerging tests for identifying NOD patients at high risk for having PDAC.


References
Maitra A, Sharma A, Brand RE, Van Den Eeden SK, Fisher WE, Hart PA, Hughes SJ, Mather KJ, Pandol SJ, Park WG, Feng Z, Serrano J, Rinaudo JAS, Srivastava S, Chari ST. A Prospective Study to Establish a New-Onset Diabetes Cohort: From the Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer. Pancreas, 47:1244-1248, 2018.