Status:
ACTIVE_NOT_RECRUITING
Early Detection Initiative for Pancreatic Cancer
Lead Sponsor:
Pancreatic Cancer Action Network
Conditions:
Hyperglycemia
Diabetes Mellitus
Eligibility:
All Genders
50-85 years
Phase:
NA
Brief Summary
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 dia...
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 glycemica...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2028
Estimated Enrollment :
8869 Patients enrolled
Trial Details
Trial ID
NCT04662879
Start Date
October 14 2021
End Date
January 1 2028
Last Update
June 8 2025
Active Locations (2)
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1
Kaiser Permanente Southern California, Kaiser Permanente Research
Pasadena, California, United States, 91101
2
Baylor College of Medicine
Houston, Texas, United States, 77030