Early Detection Initiative for Pancreatic Cancer (NCT04662879) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Detection Initiative for Pancreatic Cancer
United States8,869 participantsStarted 2021-10-14
Plain-language 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.
Who can participate
Age range50 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
…
What they're measuring
1
Validate the ENDPAC model
Timeframe: Baseline and approximately every six months for up to three years
2
Quantify potentially clinically meaningful lead time for earlier detection of PDAC
Timeframe: Baseline and approximately every six months for up to three years