NCT04662879

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8,869 (actual)
• Sponsor: Pancreatic Cancer Action Network · Academic / Other
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Not accepted

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.

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 glycemically defined new-onset diabetes for pancreatic cancer. The study will also determine with elevated ENDPAC score occurs at a clinically meaningful lead time (\>/= 4 months) before pancreatic cancer diagnosis. Eligible patients are identified and enrolled based on a first-time elevation in fasting blood glucose parameters or glycated hemoglobin (HbA1c) to the level indicating glycemically defined new-onset diabetes as derived from records in their EMR. At sites performing the Intervention component of the study, all enrolled participants will have the Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score calculated using age, body weight and glucose or glycated hemoglobin values in their EMR. Patients with high ENDPAC score (\>0) are approached for informed consent to participate in up to two imaging studies by computerized tomography (CT) scan or magnetic resonance imaging (MRI). In addition to imaging, participants will be asked to complete a study questionnaire. At sites that do not perform the Intervention component of the study, participants will be identified, enrolled, and followed by EMR data only. All enrolled participants are followed for development of PDAC. This study is performed at locations with broad (institutional) consent for use of patient EMR information for research studies. Passive follow-up by EMR will occur for three years following enrollment. Any patient that has declined participation in EMR-based research at the institution is not included in the study.

Conditions

• Hyperglycemia
• Diabetes Mellitus
• Pancreas Ductal Adenocarcinoma

Interventions

Type	Name	Description
OTHER	Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score	ENDPAC is a model to risk-stratify patients with new onset diabetes and hyperglycemia for PDAC. Score is calculated using i) age, ii) change, over past year, in body weight and iii) change, over past year, in glucose/HbA1c values obtained from the electronic medical record.
OTHER	Abdominal imaging	Using computerized tomography (CT) scan or magnetic resonance imaging (MRI), if CT scan is contra-indicated, patients with a high ENDPAC score (\>0) are approached for informed consent to participate in the imaging intervention. Imaging (CT scan) is performed at up to two time points, study baseline and approximately 3-9 months following the first imaging study.

Timeline

• Start date: 2021-10-14
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2020-12-10
• Last updated: 2026-03-12

Locations

2 sites across 1 country: United States