PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer (PRO-TECT)

Kaiser Permanente

Status: Active, not recruiting

Conditions: Pancreatic Ductal Adenocarcinoma (PDAC); Pancreatic Cancer

Treatments: Diagnostic Test: Magnetic resonance imaging (MRI)

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04883450

R01CA230442 (U.S. NIH Grant/Contract)

12135

Details and patient eligibility

About

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

Full 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.

Enrollment: 126 patients

Sex: All

Ages: 50 to 84 years old

Volunteers: No Healthy Volunteers

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

Trial design

126 participants in 1 patient group

Risk of pancreatic cancer

Description:

Subjects with an increased predicted 18-month risk of pancreatic cancer

Treatment:

Diagnostic Test: Magnetic resonance imaging (MRI)