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
- Diseases
- Pancreatic cancer
- 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
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Baylor College of Medicine Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Kaiser Permanente Southern California, Kaiser Permanente Research Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.