Early Detection Initiative for Pancreatic Cancer (EDI)

March 10, 2026 updated by: Pancreatic Cancer Action Network

A Prospective Study of Algorithm-based Screening in Patients With Glycemically Defined New Onset Diabetes to Evaluate Risk for and Earlier Detection of Pancreatic Ductal Adenocarcinoma; Early Detection Initiative (EDI) 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 glycemically defined new onset hyperglycemia and diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The Early Detection Initiative (EDI), is designed to prospectively evaluate the performance characteristics of the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) model to enrich glycemically defined new-onset diabetes for pancreatic cancer. The study will also determine with elevated ENDPAC score occurs at a clinically meaningful lead time (>/= 4 months) before pancreatic cancer diagnosis.

Eligible patients are identified and enrolled based on a first-time elevation in fasting blood glucose parameters or glycated hemoglobin (HbA1c) to the level indicating glycemically defined new-onset diabetes as derived from records in their EMR. At sites performing the Intervention component of the study, all enrolled participants will have the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated using age, body weight and glucose or glycated hemoglobin values in their EMR. Patients with high ENDPAC score (>0) are approached for informed consent to participate in up to two imaging studies by computerized tomography (CT) scan or magnetic resonance imaging (MRI). In addition to imaging, participants will be asked to complete a study questionnaire. At sites that do not perform the Intervention component of the study, participants will be identified, enrolled, and followed by EMR data only. All enrolled participants are followed for development of PDAC.

This study is performed at locations with broad (institutional) consent for use of patient EMR information for research studies. Passive follow-up by EMR will occur for three years following enrollment. Any patient that has declined participation in EMR-based research at the institution is not included in the study.

Study Type

Interventional

Enrollment (Actual)

8869

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91101
        • Kaiser Permanente Southern California, Kaiser Permanente Research
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient must have given institutional consent for minimal risk studies.
  • Patient must be ≥50 and ≤85 years of age at the time of diagnosis [index date Parameters of Diabetes Mellitus (PDM)].
  • Patient must have index weight and left-window weight values available in electronic medical record (EMR).
  • Patient must have hyperglycemia and/or diabetes as one of the following (all glycemic parameters, except for HbA1c, must be measured in an outpatient setting):

A. Glycated hemoglobin (HbA1c) ≥ 6.5%

OR

B. Any (2) PDMs on consecutive (≤90 days between PDMs) or simultaneous testing:

  • Fasting Blood Glucose (FBG) ≥126 mg/dl
  • Glycated hemoglobin (HbA1c) ≥ 6.5%
  • Random Blood Glucose (RBG) ≥200 mg/dl
  • 2 hour Post Glucose (PG) ≥ 200mg (11.1 mmol/L) during oral glucose tolerance test (OGTT)

OR

C. Any one (1) PDM present followed by an anti- diabetes medication ≤90 days after the index PDM date

  • Patient must have ≥1 glycemic parameter measured in the past 91-548 days prior to the index PDM date (Left Window) without meeting inclusion criteria A, B, or C.
  • For Intervention Sites, patients must meet inclusion criteria A, B, or C ≤90 days prior to enrollment.

Exclusion Criteria:

  • Patient has declined institutional consent for minimal risk studies.

  • Patient must not have any known past history of hyperglycemia and/or diabetes as defined by inclusion criteria A, B, or C

    *Transient diabetes (e.g. gestational and steroid-induced) is not an exclusion.

  • Patient must not be on ongoing active treatment for cancer, and/or carry a current diagnosis of any cancer (except non-melanoma skin cancer). Non-invasive cancer of any organ (carcinoma-in-situ/high grade dysplasia) is not an exclusion.

    *Ongoing work up for suspicion of pancreatic cancer is not an exclusion.

  • Patient must not have had a definitive diagnosis of pancreatic cancer prior to index PDM date.
  • Patient must not be on any anti-diabetes medications prior to index PDM date.

  • Patient must not be on chronic or acute use of steroid medications ≤90 days prior to the index PDM date.

    *Allowed: Nasal, topical steroids, oral budesonide, ophthalmic

  • Patient must not have had an intra-articular steroid injection ≤ 7 days prior to the index PDM date.
  • Patient must have values available in the EMR to calculate the ENDPAC score.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm (Site)

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.
Other: Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score
ENDPAC is a model to risk-stratify patients with new onset diabetes and hyperglycemia for PDAC. Score is calculated using i) age, ii) change, over past year, in body weight and iii) change, over past year, in glucose/HbA1c values obtained from the electronic medical record.
Other: Abdominal imaging
Using computerized tomography (CT) scan or magnetic resonance imaging (MRI), if CT scan is contra-indicated, patients with a high ENDPAC score (>0) are approached for informed consent to participate in the imaging intervention. Imaging (CT scan) is performed at up to two time points, study baseline and approximately 3-9 months following the first imaging study.
No Intervention: Observation Arm (Site)
Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validate the ENDPAC model
Time Frame: Baseline and approximately every six months for up to three years
Prospectively validate the ENDPAC model.
Baseline and approximately every six months for up to three years
Quantify potentially clinically meaningful lead time for earlier detection of PDAC
Time Frame: Baseline and approximately every six months for up to three years
Measure the duration from G-NOD to date of clinical diagnosis of PDAC.
Baseline and approximately every six months for up to three years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the risk of PDAC in G-NOD
Time Frame: Baseline and approximately every six months for up to three years
Estimate the risk of PDAC in G-NOD in the average risk population including potentially clinically meaningful lead time for earlier detection of PDAC.
Baseline and approximately every six months for up to three years
Proportion of incidental findings on imaging
Time Frame: Baseline and imaging follow-up visit, up to 9 months
Evaluate, on imaging at the time of G-NOD, the proportion with incidental findings including those that require clinical work-up.
Baseline and imaging follow-up visit, up to 9 months
Risk of PDAC by subgroups
Time Frame: Baseline and approximately every six months for up to three years
Estimate the risk of PDAC in the study population by racial and ethnic groups.
Baseline and approximately every six months for up to three years
Reasons consent for intervention was declined
Time Frame: Baseline and approximately every six months for up to five years
Evaluate the reasons invited participants decline consent for imaging intervention.
Baseline and approximately every six months for up to five years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stage of disease at PDAC diagnosis
Time Frame: Baseline and approximately every six months for up to three years
Evaluate the distribution and stage of disease at the time of PDAC diagnosis in participants with and without study imaging.
Baseline and approximately every six months for up to three years
Glycemic parameters for ENDPAC model
Time Frame: Baseline and approximately every six months for up to three years
Compare original ENDPAC score model to the modified ENDPAC score in the proportion of PDAC captured and lead time.
Baseline and approximately every six months for up to three years
ENDPAC model by subgroups
Time Frame: Baseline and approximately every six months for up to three years
Evaluate the proportion of PDAC captured and distribution of lead time across racial and ethnic populations.
Baseline and approximately every six months for up to three years
Depression and Anxiety as early indicators
Time Frame: Baseline visit
Capture the proportion of PDAC with symptoms of depression and anxiety, and how early it occurs before clinical diagnosis.
Baseline visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pancreatic Cancer Action Network

Collaborators

Fred Hutchinson Cancer Center

Investigators

  • Study Chair: Suresh Chari, MD, M.D. Anderson Cancer Center
  • Principal Investigator: Anirban Maitra, MBBS, M.D. Anderson Cancer Center
  • Principal Investigator: Bechien Wu, MD, Kaiser Permanente
  • Principal Investigator: Avinash Kambadakone-Ramesh, MD, FRCR, Massachusetts General Hospital
  • Principal Investigator: Ziding Feng, PhD, Fred Hutchinson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2021

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

November 20, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 466
  • STU25020081 (Other Identifier: Univo Institutional Review Board)
  • ONC-15162 (Other Identifier: Contract Research Organization)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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