PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer

Active, not recruiting

• Conditions: Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Cancer
• Interventions: Diagnostic Test: Magnetic resonance imaging (MRI)

• Registration Number: NCT04883450
• Lead Sponsor: Kaiser Permanente

Brief Summary

Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.

Detailed Description

The goal of this study is to establish a platform for development and implementation of a data-driven risk model for detection of early stage pancreatic cancer within an integrated health care setting. Patients at increased risk for pancreatic cancer as identified by the risk model will be invited to participate in a prospective study to assess the accuracy of this approach for detection of early stage pancreatic cancer.

Study Timeline

• Study Start: 2021-02-01
• Study First Submitted: 2021-05-07
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-12
• Last Update Posted: 2024-01-16
• Primary Completion: 2024-12-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

1. Patient must have 6 months of membership
2. Patient has a measure for weight, Hemoglobin A1C, and Alanine transaminase (ALT) within the past 6 months
3. Patient must have an increased predicted 18-month risk of pancreatic cancer based on the PRO-TECT model
4. Speaks English or Spanish

Exclusion Criteria

1. Previous or current history of pancreatic cancer
2. Metastatic cancer
3. Current active cancer or undergoing chemotherapy for cancer
4. Currently pregnant or breastfeeding
5. Class IV heart failure
6. Cirrhosis with ascites and/or varices
7. Currently in a skilled nursing facility or under hospice care
8. Has metal parts or implanted devices in the body, such as a pacemaker, defibrillator, or shrapnel
9. End stage renal disease
10. Cognitive impairment such that the person is unable to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Risk of pancreatic cancer	Magnetic resonance imaging (MRI)	Subjects with an increased predicted 18-month risk of pancreatic cancer

Primary Outcome Measures

Name	Time	Method
Incidence of pancreatic ductal adenocarcinoma (PDAC) in the high predicted risk group	18-Month	Enrolled subjects will be followed for 18 months to determine the incidence rate of PDAC

Trial Locations

Locations (1)

Kaiser Permanente Southern California; 🇺🇸 Pasadena, California, United States