PRedictiOn Algorithms for the DeTECTion of Early Stage Pancreatic Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04883450

Acronym

PRO-TECT

Enrollment

126

Registered

2021-05-12

Start date

2021-02-01

Completion date

2025-06-30

Last updated

2024-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer, Pancreatic Ductal Adenocarcinoma (PDAC)

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.

Interventions

DIAGNOSTIC_TESTMagnetic resonance imaging (MRI)

All enrolled participants will undergo magnetic resonance imaging (MRI) at their Baseline and 18-Month follow-up visit

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 84 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026