Pancreatic Cancer Detection Test for New-Onset Diabetes

Overseen By Judy Sheard, MPH, CCRA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Bluestar Genomics Inc.

Must not be taking: Anti-DM, Steroids

Disqualifiers: Pancreatic lesions, Active cancers, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

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. ^{1 2 3 4 5}

Why 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. ^{2 6 7 8 9}

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

Your blood sugar levels have been checked within the last 3-18 months, and you do not meet the criteria for diabetes.

Must be willing to provide several tubes of blood without endangering health

I have never had pancreatic cancer.

Exclusion Criteria

I have not had HIV/AIDS, Hepatitis A or E, TB, or any prion disorder like CJD in the last 5 years.

I have lesions in my pancreas.

I have been diagnosed with diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Initial Testing

Participants undergo initial blood draw and testing at the time of enrollment

0 weeks

1 visit (in-person)

Ongoing Testing

Participants undergo additional blood draws and testing at 6 and 12 months from diabetes diagnosis

12 months

2 visits (in-person)

Follow-up

Participants are monitored through electronic medical records review 24 months from diabetes diagnosis

24 months

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?

Group I: EpiDetect Arm Experimental Treatment 1 Intervention

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.

Group II: EpiDetect "not detected" MRI Arm Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Bluestar Genomics Inc.

Lead Sponsor

Trials

3

Recruited

16,500+

ClearNote Health

Lead Sponsor

Trials

4

Recruited

31,500+

Published Research Related to This Trial

Screening for pancreatic cancer (PC) is crucial for high-risk patients, as it can lead to the early detection of premalignant lesions like high-grade pancreatic intraepithelial neoplasia and intraductal papillary mucinous neoplasm.

Endoscopic ultrasound (EUS) and magnetic resonance imaging are the most accurate imaging techniques for detecting PC, with EUS offering the added benefit of tissue sampling for diagnosis and molecular profiling, making it a promising tool in specialized research settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New strategies for the early detection of pancreatic cancer. Petrone, MC., Arcidiacono, PG.[2016]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2840294

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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41105406/

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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04662879

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 ...

4. healio.com healio.com/news/hematology-oncology/20250806/major-milestone-study-validates-newonset-diabetes-as-early-pancreatic-cancer-marker

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 ...

5. academic.oup.com academic.oup.com/jcem/advance-article/doi/10.1210/clinem/dgaf319/8152681

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.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8144346/

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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8844106/

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 ...

8. cghjournal.org cghjournal.org/article/S1542-3565(22)00141-0/fulltext

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 ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05188586

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 ...