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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
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I have high blood sugar or diabetes.
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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:
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I have never been diagnosed with diabetes or high blood sugar.
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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.
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I have chosen not to participate in low-risk studies.
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I am not taking any diabetes medications before my PDM date.
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I have never been diagnosed with pancreatic cancer before the specified date.

Timeline

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.

Find a Location

Who is running the clinical trial?

Pancreatic Cancer Action NetworkLead Sponsor
5 Previous Clinical Trials
962 Total Patients Enrolled
Fred Hutchinson Cancer CenterOTHER
571 Previous Clinical Trials
1,326,395 Total Patients Enrolled
5 Trials studying Diabetes
3,135 Patients Enrolled for Diabetes
National Institutes of Health (NIH)NIH
2,843 Previous Clinical Trials
8,164,233 Total Patients Enrolled
25 Trials studying Diabetes
64,177 Patients Enrolled for Diabetes
Suresh Chari, MDStudy ChairM.D. Anderson Cancer Center
1 Previous Clinical Trials
2,270 Total Patients Enrolled
1 Trials studying Diabetes
2,270 Patients Enrolled for Diabetes
Anirban Maitra, MBBSPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
2,270 Total Patients Enrolled
1 Trials studying Diabetes
2,270 Patients Enrolled for Diabetes
Bechien Wu, MDPrincipal InvestigatorKaiser Permanente
1 Previous Clinical Trials
2,270 Total Patients Enrolled
1 Trials studying Diabetes
2,270 Patients Enrolled for Diabetes
Avinash Kambadakone-Ramesh, MD, FRCRPrincipal InvestigatorMassachusetts General Hospital
Ziding Feng, PhDPrincipal InvestigatorFred Hutchinson Cancer Center
Jackie DahlgrenStudy DirectorFred Hutchinson Cancer Center

Media Library

Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score (Algorithm-based Screening) Clinical Trial Eligibility Overview. Trial Name: NCT04662879 — N/A
Diabetes Research Study Groups: Intervention Arm (Site), Observation Arm (Site)
Diabetes Clinical Trial 2023: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score Highlights & Side Effects. Trial Name: NCT04662879 — N/A
Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score (Algorithm-based Screening) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04662879 — N/A
~4671 spots leftby Jun 2028