Diabetes Screening for Early Detection of Pancreatic Cancer

(EDI Trial)

Recruiting at 2 trial locations

Overseen By Nadia Yosuf, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Pancreatic Cancer Action Network

Must not be taking: Anti-diabetes, Steroids

Disqualifiers: Cancer, Pancreatic cancer, others

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

Compensation: Varies

Number of Visits: Unknown

9000 Participants Needed

Trial Summary

What is the purpose of this trial?

The Early Detection Initiative for Pancreatic Cancer is a multi-center prospective study to determine if algorithm-based screening in patients with glycemically defined new onset hyperglycemia and diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma.

Do I need to stop my current medications for this trial?

The trial requires that you are not on any anti-diabetes medications before the start date. If you are currently taking such medications, you may need to stop them to participate.

What data supports the effectiveness of the treatment Abdominal imaging, Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score for early detection of pancreatic cancer?

Research shows that people over 50 who develop new diabetes have a higher risk of pancreatic cancer, and the ENDPAC score helps identify those at higher risk. Using this score along with CT scans aims to catch pancreatic cancer early when surgery is still possible. ^{1 2 3 4 5}

Is the ENDPAC score and abdominal imaging safe for humans?

The ENDPAC score and abdominal imaging, like CT scans, are generally considered safe for humans. The study includes an estimate of potential harm, suggesting that safety is being monitored. ^{1 2 6 7 8}

How is the ENDPAC score treatment different from other treatments for pancreatic cancer?

The ENDPAC score is unique because it is not a drug but a screening tool designed to identify people with new-onset diabetes who are at higher risk of developing pancreatic cancer. This approach focuses on early detection rather than treatment, which is crucial because pancreatic cancer is often diagnosed at a late stage. ^{2 3 6 8 9}

Research Team

Anirban Maitra, MBBS

Principal Investigator

M.D. Anderson Cancer Center

Avinash Kambadakone-Ramesh, MD, FRCR

Principal Investigator

Massachusetts General Hospital

Suresh Chari, MD

Principal Investigator

M.D. Anderson Cancer Center

Bechien Wu, MD

Principal Investigator

Kaiser Permanente

Ziding Feng, PhD

Principal Investigator

Fred Hutchinson Cancer Center

Eligibility Criteria

This trial is for people aged 50-85 who've recently developed high blood sugar or diabetes, as shown in their medical records. They must consent to the study and not be on any cancer treatments, have no history of hyperglycemia/diabetes or pancreatic cancer diagnosis before the study start date, and not be taking steroids.

Inclusion Criteria

I have high blood sugar or diabetes.

Patient must have index weight and left-window weight values available in electronic medical record (EMR)

I am between 50 and 85 years old and was diagnosed with diabetes.

Exclusion Criteria

I have never been diagnosed with diabetes or high blood sugar.

I haven't had a steroid injection into a joint in the last week.

I am not currently receiving cancer treatment, nor am I being investigated for cancer recurrence, except for non-melanoma skin cancer or cervical carcinoma in-situ.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants with high ENDPAC scores undergo imaging studies and complete a study questionnaire

Up to 9 months

Baseline and imaging follow-up visit

Observation

Participants are followed by electronic medical record for study endpoints of pancreatic cancer diagnosis

Up to 3 years

Baseline and approximately every six months

Follow-up

Participants are monitored for safety and effectiveness after intervention

Up to 3 years

Passive follow-up by EMR

Treatment Details

Interventions

• Abdominal imaging
• Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score

Trial Overview The trial tests if a special score (ENDPAC) combined with abdominal imaging can find pancreatic cancer early in those newly diagnosed with high blood sugar or diabetes. It's a randomized controlled trial across multiple centers.

Participant Groups

Group I: Intervention Arm (Site) Experimental Treatment 2 Interventions

Two interventions are performed: 1. Have Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated, and if Score is \>0, 2. Have abdominal imaging performed.

Group II: Observation Arm (Site) Active Control 1 Intervention

Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.

Who Is Running the Clinical Trial?

Pancreatic Cancer Action Network

Lead Sponsor

Trials

6

Recruited

10,000+

Fred Hutchinson Cancer Center

Collaborator

Trials

583

Recruited

1,341,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

References

1. 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]

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

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

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Prognostic Role of Glycemia in Patients With Pancreatic Carcinoma: A Systematic Review and Meta-Analysis. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring the bi-directional relationship between pancreatic cancer and diabetes mellitus: a retrospective study. [2020]

5. China pubmed.ncbi.nlm.nih.gov

The early diagnosis of pancreatic cancer and diabetes: what's the relationship? [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

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

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

Validation of the Enriching New-Onset Diabetes for Pancreatic Cancer Model: A Retrospective Cohort Study Using Real-World Data. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Newly diagnosed type 2 diabetes may serve as a potential marker for pancreatic cancer. [2019]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Weight change and blood glucose concentration as markers for pancreatic cancer in subjects with new-onset diabetes mellitus: A matched case-control study. [2022]