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

NCT04662879 NA ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Pancreatic Cancer Action Network
Phase	NA
Status	ACTIVE_NOT_RECRUITING
Enrolment	8869
Start date	2021-10-14
Completion	2028-01

Conditions

• Hyperglycemia
• Diabetes Mellitus
• Pancreas Ductal Adenocarcinoma

Interventions

• Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score
• Abdominal imaging

Primary outcomes

• Validate the ENDPAC model — Baseline and approximately every six months for up to three years
  Prospectively validate the ENDPAC model.
• Quantify potentially clinically meaningful lead time for earlier detection of PDAC — Baseline and approximately every six months for up to three years
  Measure the duration from G-NOD to date of clinical diagnosis of PDAC.

Countries

United States