Early Detection Initiative for Pancreatic Cancer

Running, not enrolling · Not applicable

Conditions studied: Hyperglycemia, Diabetes Mellitus, Pancreas Ductal Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT04662879

Run by

Pancreatic Cancer Action Network

People needed

8869

Starts

2021-10-14

Expected to finish

2028-01-01

Last updated by the study team

2026-03-12

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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