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

January 12, 2024 updated by: Kaiser Permanente
Conduct a prospective study to assess the accuracy of a pancreatic cancer risk prediction model.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Pasadena, California, United States, 91101
        • Kaiser Permanente Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Kaiser Permanente Southern California with at least 12 months prior to recruitment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Risk of pancreatic cancer
Subjects with an increased predicted 18-month risk of pancreatic cancer
Diagnostic test: Magnetic resonance imaging (MRI)
All enrolled participants will undergo magnetic resonance imaging (MRI) at their Baseline and 18-Month follow-up visit

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kaiser Permanente

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Bechien U Wu, MD, MPH, Kaiser Permanente

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Estimated)

January 15, 2024

Last Update Submitted That Met QC Criteria

January 12, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12135
  • R01CA230442 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pancreatic Cancer

Clinical Trials on Magnetic resonance imaging (MRI)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe