← Back to Search

Algorithm-based Screening

Diabetes Screening for Early Detection of Pancreatic Cancer (EDI Trial)

N/A

Waitlist Available

Led By Anirban Maitra, MBBS

Research Sponsored by Pancreatic Cancer Action Network

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient must have hyperglycemia and/or diabetes as defined by specific glycemic parameters

Patient must be ≥50 and ≤85 years of age at the time of diagnosis (index date Parameters of Diabetes Mellitus (PDM))

Must not have

Patient must not have any known past history of hyperglycemia and/or diabetes as defined by specific inclusion criteria

Patient must not be on active treatment for cancer, carry a current diagnosis of any cancer, and/or investigated for suspicion of recurrence of past cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and approximately every six months for up to three years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether screening people with new onset diabetes can help detect pancreatic cancer earlier.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic procedures rather than medications, typical drug side effects are not expected. However, there may be minimal risks associated with undergoing abdominal imaging.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have high blood sugar or diabetes.

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

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.

Select...

I have chosen not to participate in low-risk studies.

Select...

I am not taking any diabetes medications before my PDM date.

Select...

I have never been diagnosed with pancreatic cancer before the specified date.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and approximately every six months for up to three years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and approximately every six months for up to three years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and approximately every six months for up to three years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Quantify potentially clinically meaningful lead time for earlier detection of PDAC

Validate the ENDPAC model

Secondary study objectives

Evaluate the risk of PDAC in G-NOD

Proportion of incidental findings on imaging

Reasons consent for intervention was declined

+1 more

Other study objectives

Depression and Anxiety as early indicators

ENDPAC model by subgroups

Glycemic parameters for ENDPAC model

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Arm (Site)Experimental Treatment2 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 Control1 Intervention

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

0 / 7Eligibility criteria met