Link Between Pancreatic Cancer and Newly Diagnosed Type 2 Diabetes
Adults with newly diagnosed type 2 diabetes are at higher risk of having undetected pancreatic cancer. A U.S. clinical trial is recruiting this population to evaluate a screening blood test that aids in its early detection.
Clinical Trials Identifier: NCT05188586
Trial Name: New Onset Diabetes Management for Earlier Detection of Pancreatic Cancer (NODMED)
Diabetes Type: Newly diagnosed type 2 diabetes
Trial Sponsor: Bluestar Genomics Inc.
Why is this trial new and important?
Research shows that older adults with new-onset type 2 diabetes have 8 times the risk of having pancreatic cancer, and that one in four people with pancreatic cancer has diabetes. Unfortunately, most people don’t experience any symptoms of pancreatic cancer until it has advanced enough that surgery is no longer possible and treatment options are limited.
The good news is that pancreatic cancer is potentially curable if caught very early. The earlier pancreatic cancer can be detected, the greater the treatment options and the better the prognosis. There is currently no screening protocol for pancreatic cancer, and conducting imaging tests on every adult newly diagnosed with diabetes would not be feasible and might not be helpful. An easily administered blood test that could detect pancreatic cancer before symptoms arise would be an important, potentially life-saving advancement.
What is the trial testing?
NODMED is a trial evaluating Bluestar Genomics’ DNA-based blood test for the early detection of pancreatic cancer, with an estimated enrollment of 6,500 men and women aged 50 or older with newly diagnosed type 2 diabetes (within 90 days before study enrollment).
Participants will be divided into two groups: adults aged 50 to 64 years, and those aged 65 and older. All individuals will undergo two blood draws (one within 90 days of diabetes diagnosis and another 6 months after diagnosis) and a search of their medical records from the past year.
Individuals whose test results indicate possible detection of pancreatic cancer will undergo MRI imaging and be referred for follow-up diagnostic workup and care.
The primary goals of this study are to measure the test’s ability in people with newly diagnosed diabetes to accurately identify individuals with pancreatic cancer (the probability that a person with a positive test result actually has cancer) and its ability to accurately predict the absence of pancreatic cancer (the probability that a person with a negative test result truly does not have pancreatic cancer). The secondary goal is to determine the average time to pancreatic cancer diagnosis in people with newly diagnosed type 2 diabetes using this screening test versus those not using this test, based on previously published data.
Trial Length: 12 months
Trial Locations: This is a multicenter study with several locations across the United States. Click here to see a list of all participating locations.
Are you interested?
You may be eligible to participate in this trial if you:
- Are 50 years or older in age
- Were diagnosed with type 2 diabetes within the past 90 days at your doctor’s office (not in urgent care, emergency department, or a hospital stay)
- Had blood tests showing no indications of diabetes 3-18 months before your eventual diabetes diagnosis
- Have no history of pancreatic disease
- Had no active cancers within the past 5 years
You can see a full list of eligibility and exclusion criteria here.
For more information: Please contact Anna Bergamaschi of Bluestar Genomics at (650) 714-9212 or [email protected], or Melissa Peters at [email protected].