Early Detection Initiative for Pancreatic Cancer (EDI)

July 11, 2023 updated by: Pancreatic Cancer Action Network

A Randomized Controlled Trial of Algorithm-based Screening in Patients With New Onset Hyperglycemia and Diabetes for Early Detection of Pancreatic Ductal Adenocarcinoma (Early Detection Initiative (EDI) for Pancreatic Cancer)

The Early Detection Initiative for Pancreatic Cancer is a multi-center randomized controlled trial to determine if algorithm-based screening in patients with new onset hyperglycemia and diabetes can result in earlier detection of pancreatic ductal adenocarcinoma.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The Early Detection Initiative (EDI), is designed to evaluate if imaging at the time of new onset hyperglycemia and diabetes, especially at its earliest discovery through passive surveillance of the electronic medical record (EMR), results in earlier detection of pancreatic ductal adenocarcinoma (PDAC).

Eligible patients are identified and enrolled based on a first-time elevation in fasting blood glucose or glycated hemoglobin (HbA1c) to the level indicating diabetes as derived from records in their EMR. All enrolled patients are randomized to either the Observational Arm or Intervention Arm of the study. Patients randomized to the Intervention Arm have 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 study questionnaires and participate in serial blood collection at up to five time points. Blood samples collected in the EDI study will contribute to the National Institutes of Health (NIH) National Cancer Institute (NCI) biorepository located at the Frederick National Laboratory for Cancer Research facility. Patients in both study arms 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 five 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 (Estimated)

12500

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 Contact

Study Contact Backup

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 ≤90 days prior to randomization (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.

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 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).

    *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.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Arm

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
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
Earlier detection of pancreatic ductal adenocarcinoma (PDAC)
Time Frame: Baseline and approximately every six months for up to five years
Determine if algorithm-based screening in new onset hyperglycemia and diabetes (NOD) results in earlier detection of pancreatic ductal adenocarcinoma (PDAC) as evidenced by a lower proportion of Stage III/IV disease at the time of PDAC diagnosis in intervention vs observation arm.
Baseline and approximately every six months for up to five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smaller proportion of unresectable disease
Time Frame: Baseline and approximately every six months for up to five years
Determine if Intervention results in earlier detection of PDAC defined as a smaller proportion of unresectable disease.
Baseline and approximately every six months for up to five years
Less Stage IV disease
Time Frame: Baseline and approximately every six months for up to five years
Determine if Intervention results in earlier detection of PDAC defined as less Stage IV disease.
Baseline and approximately every six months for up to five years
Smaller proportion with advanced pancreatic cancer symptoms
Time Frame: Baseline and approximately every six months for up to five years
Determine if Intervention results in earlier detection of PDAC defined as a smaller proportion with advanced pancreatic cancer symptoms.
Baseline and approximately every six months for up to five years
Estimating risk in subgroups
Time Frame: Baseline and approximately every six months for up to five years
Estimate the risk of PDAC in NOD and Enriching New-onset Diabetes (or hyperglycemia) for Pancreatic Cancer (ENDPAC) subgroups.
Baseline and approximately every six months for up to five years
Validate ENDPAC model
Time Frame: Baseline and approximately every six months for up to five years
Prospectively validate the ENDPAC model.
Baseline and approximately every six months for up to five years
Over diagnosis due to imaging intervention of NOD
Time Frame: Baseline and imaging follow-up visit, up to 9 months
Determine the magnitude of over diagnosis due to imaging intervention of NOD.
Baseline and imaging follow-up visit, up to 9 months
Determine the proportion of incidental findings
Time Frame: Baseline and approximately every six months for up to five years
Determine, on imaging in NOD, the proportion with incidental findings that require clinical workup.
Baseline and approximately every six months for up to five years
Contribute to NOD biobank
Time Frame: Baseline and blood collection follow-up visits, up to 36 months
Contribute blood biospecimens to a previously established NOD cohort biobank for future biomarker validation studies.
Baseline and blood collection follow-up visits, up to 36 months
Depression and Anxiety as early indicators
Time Frame: Baseline and follow-up visits
Determine if symptoms of depression and anxiety are early indicators of PDAC.
Baseline and follow-up visits

Collaborators and Investigators

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

Sponsor

Pancreatic Cancer Action Network

Collaborators

National Institutes of Health (NIH)
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
  • Study Director: Jackie Dahlgren, 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)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

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)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 466
  • RG1007916 (Other Identifier: Fred Hutchinson Research Center)
  • FHIRB0010533 (Other Identifier: Fred Hutchinson Institutional Review Board)

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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