Pancreatic Cancer Detection Test for New-Onset Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new blood test designed to detect hidden pancreatic cancer in individuals recently diagnosed with type II diabetes. The goal is to evaluate the test's effectiveness in early cancer detection. If the test indicates possible cancer, participants will undergo an MRI scan for confirmation. Individuals aged 50 or older, diagnosed with type II diabetes within the last three months, and with no history of pancreatic issues may qualify. As an unphased trial, this study provides participants the chance to contribute to groundbreaking research that could lead to earlier detection of pancreatic cancer.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are using anti-diabetes medications or chronic oral steroids, you may not be eligible to participate.
What prior data suggests that this early detection pancreatic cancer test is safe?
Research has shown that the early detection test for pancreatic cancer is generally safe. This non-invasive test does not involve surgery or entering the body; it only requires a simple blood draw, a routine and well-tolerated procedure. No major reports have linked problems directly to this test.
When combined with MRI (Magnetic Resonance Imaging), a common method used in many medical diagnoses, the process remains safe. MRI does not use radiation and is considered safe for most people. Some individuals might feel uncomfortable lying still or being in a small space during the scan, but serious side effects are rare.
Overall, both the test and the MRI are well-tolerated and carry minimal risk. Participants should discuss any concerns with the study team or their doctor before participating.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to improve the early detection of pancreatic cancer, a challenging task with current methods. Unlike traditional approaches that typically rely on imaging techniques after symptoms appear, this trial explores a blood test for early detection in patients with new-onset diabetes, which can signal an increased risk for pancreatic cancer. Additionally, the use of MRI imaging for certain patients enhances monitoring capabilities, potentially identifying cancer at a more treatable stage. By focusing on early detection, these methods could lead to better outcomes and less invasive treatment options for patients.
What evidence suggests that this early detection pancreatic cancer test is effective for detecting pancreatic cancer in patients with new-onset diabetes?
Research has shown that developing diabetes later in life can signal early pancreatic cancer, particularly in individuals over 50. Studies indicate these individuals face a 6- to 8-times higher risk of developing pancreatic cancer. In this trial, participants will join one of two groups: one will receive only the early detection test, while the other will receive the test along with MRI imaging. Previous research found that combining this test with MRI scans improved early cancer detection. For those with new-onset diabetes, early cancer detection can significantly enhance treatment success.26789
Who Is on the Research Team?
Kelly Bethel, MD
Principal Investigator
Bluestar Genomics
Are You a Good Fit for This Trial?
This trial is for people over 50 with new-onset type II diabetes who have never had pancreatic cancer or certain other pancreatic diseases. Participants must not have a history of any active cancers in the past five years (except some skin cancers and in situ carcinomas) and should be able to provide blood samples safely.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Enrollment and Initial Testing
Participants undergo initial blood draw and testing at the time of enrollment
Ongoing Testing
Participants undergo additional blood draws and testing at 6 and 12 months from diabetes diagnosis
Follow-up
Participants are monitored through electronic medical records review 24 months from diabetes diagnosis
What Are the Treatments Tested in This Trial?
Interventions
- Early detection pancreatic cancer test
- Early detection pancreatic cancer test and MRI Imaging
Trial Overview
The study tests Bluestar Genomics' non-invasive early detection test for hidden pancreatic cancer in patients newly diagnosed with type II diabetes. If the test indicates potential cancer, an MRI will confirm its presence. The study aims to enroll 10,000 participants.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Each subject can undergo to up to 3 blood draws; at the time of enrollment (T0), at 6 months (T1) and 12 months (T2) from diabetes diagnosis. After 24 months from diabetes diagnosis, a review of the electronic medical records (EMR) will be performed for all subjects with a "not detected" test result.
A pre-specified number of cases with test results "not detected" will be randomly selected, gender ratio and age matched to subjects with test results "detected" and will undergo MRI imaging at T0 (n=226), at T1 (n=208 ) at T2 (n=208 ) and 24 months (n=208) from diabetes diagnosis.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bluestar Genomics Inc.
Lead Sponsor
ClearNote Health
Lead Sponsor
Published Research Related to This Trial
Citations
Cost-Effectiveness of Pancreatic Cancer Screening in New ...
This economic evaluation examines the cost-effectiveness of 3 screening strategies for pancreatic ductal adenocarcinoma among individuals ...
Cost-Effectiveness of Biomarker-Associated Early ...
In this economic evaluation of early PDAC detection among individuals with new-onset diabetes, the application of a primary T3cD biomarker ...
Early Detection Initiative for Pancreatic Cancer
The Early Detection Initiative (EDI), is designed to prospectively evaluate the performance characteristics of the Enriching New-onset Diabetes for Pancreatic ...
New-onset diabetes an early marker of pancreatic cancer
Individuals with glycemically-defined new-onset diabetes exhibited a nearly fivefold higher risk for pancreatic cancer within the next 3 years ...
Pancreatic Cancer Screening in New-onset and Deteriorating ...
New-onset diabetes (NOD) in individuals ≥50 years old increases the risk 6- to 8-fold, making this group a target of early detection studies.
Early prediction of pancreatic cancer from new-onset ...
The gold standard diagnostic test for early-stage PC detection still remains contrast-enhanced multidetector CT, being 76%-97% sensitive and ...
Early Detection Initiative: A randomized controlled trial of ...
The Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) algorithm further risk stratifies NOD subjects based on age and changes in weight and diabetes ...
New-onset Diabetes as a Signpost of Early Pancreatic ...
The authors found that at threshold levels of 1% to 2% cancer risk, an early detection screening strategy could capture up to 26% to 45% of the ...
Study Details | NCT05188586 | New Onset Diabetes ...
Bluestar Genomics has developed a non-invasive test that aids in detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who ...
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