A Study to Establish a New Onset Hyperglycemia and Diabetes Cohort (NOD)
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|ClinicalTrials.gov Identifier: NCT03731637|
Recruitment Status : Active, not recruiting
First Posted : November 6, 2018
Last Update Posted : July 28, 2022
|Condition or disease|
|Diabetes Type2 Diabetes Diabetes Mellitus|
|Study Type :||Observational|
|Actual Enrollment :||2271 participants|
|Official Title:||A Prospective Study to Establish a New Onset Hyperglycemia and Diabetes (NOD) Cohort|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||December 2023|
|Estimated Study Completion Date :||June 2025|
Subjects with biochemically-defined new-onset diabetes
- Incidence of pancreatic ductal adenocarcinoma in new-onset hyperglycemia and diabetes [ Time Frame: 3 years ]Enrolled subjects will be followed for three years to determine the 1-year, 2-year, 3-year incidence rates of PDAC in new-onset hyperglycemia and diabetes.
- Determine sensitivity and specificity of serum CA 19-9 in pre-symptomatic pancreatic ductal adenocarcinoma in subjects with new-onset hyperglycemia and diabetes [ Time Frame: 3 years ]We will retrospectively measure serum CA 19-9 in blood collected at baseline and at each subsequent blood draw to determine its ability to predict pancreatic cancer in presymptomatic subjects. We will also collect blood for future biomarker testing.
Biospecimen Retention: Samples With DNA
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): NCT03731637
|Study Chair:||Suresh Chari, MD||M.D. Anderson Cancer Center|
|Study Chair:||Anirban Maitra, MBBS||M.D. Anderson Cancer Center|