Diabetes Screening for Early Detection of Pancreatic Cancer

(EDI Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score can help detect pancreatic cancer earlier in individuals with newly diagnosed high blood sugar or diabetes. Participants will either have their score calculated and possibly undergo abdominal imaging, or they will be observed through their medical records. It suits individuals recently diagnosed with high blood sugar or diabetes who have no history of cancer treatment. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to earlier detection of pancreatic cancer.

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 prior data suggests that this algorithm-based screening is safe for early detection of pancreatic cancer?

Research has shown that the ENDPAC score helps identify individuals at higher risk for pancreatic cancer, particularly those with new-onset diabetes. Studies have not identified any direct safety concerns with calculating this score. It assesses risk using age, recent weight changes, and diabetes status.

Abdominal imaging occurs if the ENDPAC score exceeds a certain level and is generally safe. Research indicates that imaging can effectively detect pancreatic cancer early in high-risk individuals. Standard imaging techniques have not reported major safety issues. However, like any medical test, minor side effects may occur, such as slight discomfort or rare allergic reactions to the contrast dye used in some scans.

Overall, these methods are well-tolerated and focus on early detection rather than direct treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ENDPAC score because it provides a new way to screen for pancreatic cancer by identifying patients with new-onset diabetes who might be at higher risk. Unlike standard care, which usually involves waiting for symptoms to appear before conducting imaging tests, the ENDPAC score allows for proactive abdominal imaging based on a calculated risk score. This approach could lead to earlier detection of pancreatic cancer, potentially improving outcomes by catching the disease at a more treatable stage.

What evidence suggests that this trial's treatments could be effective for early detection of pancreatic cancer?

In this trial, participants in the intervention arm will have their Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated. Research has shown that the ENDPAC score can identify individuals with new-onset diabetes who are at higher risk for pancreatic cancer. Studies indicate that an ENDPAC score of 3 or higher significantly increases the likelihood of early pancreatic cancer detection, even up to six months before a typical diagnosis. Early findings suggest that this score can identify a group who might benefit more from further screening.

If the ENDPAC score exceeds 0, participants will also undergo abdominal imaging. Previous studies found signs of pancreatic cancer in nearly half of the patients who had scans six to twelve months before an official diagnosis. Together, these methods aim to detect pancreatic cancer earlier, potentially leading to better outcomes for those at risk. Participants in the observation arm will have passive follow-up through electronic medical records for study endpoints of pancreatic cancer diagnosis. ^{6 7 8 9 10}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

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

Early prediction of pancreatic cancer from new-onset ... The key step towards early detection of PC is to identify well-tailored cohorts of people at high risk, to whom a suitable combination of non-invasive ...

2. 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 ...

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

Early Detection Initiative for Pancreatic Cancer The Early Detection Initiative for Pancreatic Cancer is a multi-center prospective study to determine if algorithm-based screening in patients with ...

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

Pancreatic Cancer Screening in New-onset and Deteriorating ... The 5-year survival of screen-detected cancers was 73%. The Pancreatic Cancer Early Detection consortium is a prospective, international study that expands ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1551714421003955

Early Detection Initiative: A randomized controlled trial of ... In a recent study of MDCT scans done up to 36 months prior to PDAC diagnosis, findings suggestive of PDAC were seen in the nearly half the patients 6–12 months ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11255004/

Aspects and outcomes of surveillance for individuals at high ... Several studies have investigated the outcomes of HRIs undergoing pancreatic cancer surveillance. A meta-analysis by Signoretti et al.

7. ascopubs.org ascopubs.org/doi/10.1200/OP.2025.21.10_suppl.450

Pancreatic cancer screening and outcomes in patients with ... Results: Of 194 patients who had relevant genetic testing results, 128 (65.98%) underwent abdominal imaging, while 66 (34.02%) did not. Among ...

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2820691

Pancreatic Cancer Surveillance and Survival of High-Risk ... One- and 5-year survival probabilities were 95% (95% CI, 86%-100%) and 61% (95% CI, 40%-93%), respectively, in the high-risk individuals with screen-detected ...

9. acsearch.acr.org acsearch.acr.org/docs/3099847/Narrative

Variant: 1 Adult. High-risk screening for pancreatic ductal ... Another study suggests that within the 3 to 6 months prior to diagnosis, a contrast-enhanced CT may be 86% sensitive in the identification of findings ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S2590030724000515

Pancreatic Cancer Screening: A Narrative Review The best prognosis is seen in patients with T1 PC, with a 5-year survival rate of 35%-67% after pancreatic resection., However, <10% of the operated patients ...