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Active Not Recruiting
NCT04662879
Early Detection Initiative for Pancreatic Cancer
Conditions: Hyperglycemia, Diabetes Mellitus, Pancreas Ductal Adenocarcinoma
Sex: All
Ages: 50 Years – 85 Years
Healthy volunteers: No
Phase: NA
Enrollment: 8869
Sponsor: Pancreatic Cancer Action Network
Location: Kaiser Permanente Southern California, Kaiser Permanente Research Pasadena California
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 diabetes has the potential for earlier detection of pancreatic ductal adenocarcinoma.
Eligibility Criteria
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 (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 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 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.
Source: ClinicalTrials.gov (NCT04662879). StuddyBuddy aggregates publicly available trial information.