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NCT04662879Active, not recruiting

Early Detection Initiative for Pancreatic Cancer

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

Source: ClinicalTrials.gov · Last updated 8 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
8869 (actual)
First submitted
20 Nov 2020
Start date
14 Oct 2021
Primary completion date
Jan 2028
Lead sponsor
Pancreatic Cancer Action Network
NCT number
NCT04662879

What you commit to

  • Study type: Interventional
  • Participants enrolled: 8869
  • From 14 Oct 2021 to the primary completion date, Jan 2028
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • 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.

Other

  • Patient has declined institutional consent for minimal risk studies.
  • Patient must have values available in the EMR to calculate the ENDPAC score.

Who the study is looking for

  • 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):
  • Glycated hemoglobin (HbA1c) ≥ 6.5%
    • OR
  • 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
  • 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.

Age in the registry: 50 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Baylor College of Medicine
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Kaiser Permanente Southern California, Kaiser Permanente Research
Coordinator of this site? Confirm its status
PasadenaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.