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

10000 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new blood test to find hidden pancreatic cancer in people aged 50 or older who have been diagnosed with type II diabetes. The test looks for cancer signals in the blood, and if found, an MRI scan is done to confirm the presence of 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 data supports the effectiveness of this treatment for early detection of pancreatic cancer in patients with new-onset diabetes?

Recent studies suggest that using the ENDPAC model to screen new-onset diabetes patients can help identify those at higher risk for pancreatic cancer, potentially allowing for earlier detection when surgical intervention is still possible. Advances in imaging techniques like MRI and CT scans have improved the ability to detect pancreatic tumors early, which is crucial for better treatment outcomes. ^{1 2 3 4 5}

Is the pancreatic cancer detection test for new-onset diabetes safe for humans?

The research does not provide specific safety data for the pancreatic cancer detection test in humans, but it mentions that screening should be done within research protocols at experienced centers with a multidisciplinary team, suggesting a focus on safety and expertise. ^{3 6 7 8 9}

How does the early detection pancreatic cancer test for new-onset diabetes differ from other treatments for pancreatic cancer?

This treatment is unique because it focuses on early detection of pancreatic cancer in patients with new-onset diabetes, using a combination of a specialized test and MRI imaging. Unlike traditional treatments that address cancer after diagnosis, this approach aims to identify high-risk individuals early, potentially improving outcomes by allowing for earlier intervention. ^{1 3 5 6 10}

Research Team

Kelly Bethel, MD

Principal Investigator

Bluestar Genomics

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

[Diagnostic evaluation of pancreatic carcinoma prompting treatment decisions]. [2016]

2. Japan pubmed.ncbi.nlm.nih.gov

[Recent advances in imaging diagnosis of pancreatic neoplasma with special reference to early diagnosis of the cancer]. [2016]

3. United States pubmed.ncbi.nlm.nih.gov

Early Detection Initiative: A randomized controlled trial of algorithm-based screening in patients with new onset hyperglycemia and diabetes for early detection of pancreatic ductal adenocarcinoma. [2023]

4. Italy pubmed.ncbi.nlm.nih.gov

[On the subject of pancreatic ductal carcinoma]. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Validation of the ENDPAC model: Identifying new-onset diabetics at risk of pancreatic cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

New strategies for the early detection of pancreatic cancer. [2016]

7. Belgium pubmed.ncbi.nlm.nih.gov

[Epidemiological aspects, risk factors, and detection of pancreatic cancer]. [2015]

8. Japan pubmed.ncbi.nlm.nih.gov

Pancreatic cancer: early detection, diagnosis, and screening. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Standardization of MRI Screening and Reporting in Individuals With Elevated Risk of Pancreatic Ductal Adenocarcinoma: Consensus Statement of the PRECEDE Consortium. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Machine Learning Predicts Patients With New-onset Diabetes at Risk of Pancreatic Cancer. [2023]