A Prospective Study of Algorithm-based Screening in Patients With Glycemically Defined New Onset Hyperglycemia and Diabetes to Evaluate Risk for and Earlier Detection of Pancreatic Ductal Adenocarcinoma (Early Detection Initiative (EDI) for Pancreatic Cancer)

Status: Enrolling_by_invitation
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Kaiser Permanente Southern California, Kaiser Permanente Research
Pasadena
Texas
Baylor College of Medicine
Houston
Time Frame
Start Date: 2021-10-14
Completion Date: 2028-06
Participants
Target number of participants: 9000
Treatments
Experimental: Intervention Arm (Site)
Two interventions are performed:~1. Have Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated, and if Score is \>0,~2. Have abdominal imaging performed.
No_intervention: Observation Arm (Site)
Passive follow-up by electronic medical record for study endpoints of pancreatic cancer diagnosis.
Sponsors
Leads: Pancreatic Cancer Action Network
Collaborators: Fred Hutchinson Cancer Center

This content was sourced from clinicaltrials.gov