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Active (not recruiting) NCT05973331

Prospective Validation of an EHR-based Pancreatic Cancer Risk Model

Conditions: Pancreatic Adenocarcinoma Predictive Cancer Model

Sponsor: Beth Israel Deaconess Medical Center

trial.available_in: БГ
Overview
The goal of this prospective observational cohort study is to validate a previously developed pancreatic cancer risk prediction algorith (the PRISM model) using electronic health records from the general population. The main questions it aims to answer are: * Will a pancreatic cancer risk model, developed on routine EHR data, reliably and accurately predict pancreatic cancer in real-time? * What is the average time from model deployment and risk prediction, to the date of pancreatic cancer development and what is the stage of pancreatic cancer at diagnosis? The risk model will be deployed on data from individuals eligible for the study. Each individual will be assigned a risk score and tracked over time to assess the model's discriminatory performance and calibration.
Description
To prospectively validate, implement in real-time, and assess performance of an EHR- based PDAC risk-prediction model. To test the hypothesis that our model will reliably predict PDAC in a real-time clinical setting, we will conduct a multi-center prospective cohort study, deploying the PDAC risk model within the TriNetX federated network database, and will take the following steps: i) generate a risk prediction score for each individual under the care of 44 health care organizations (HCOs) in the USA ii) follow all individuals for up to 3 years to assess the primary end-point of PDAC development. The following metrics will be used to test the discriminative performance and calibration of the EHR-based PDAC risk model in predicting incident PDAC, at the end of the 3-year period: 1. AUROC, sensitivity, specificity, PPV/NPV for assessing discrimination 2. Calibration: for assessing the accuracy of estimates, based on the estimated to observed number of events
Who can participate
Inclusion Criteria: * Male and females age \>= 40 years from 44 US HCOs from the TriNetX platform * at least 2 clinical encounters to the HCO, within the last year, before the study start date Exclusion Criteria: * Personal history of PDAC or current PDAC * Age below 40 Notes on sampling method: no sampling was performed. All eligible individuals are included in this study.
Interventions
Pancreatic Cancer Risk Model (PRISM)
OTHER
Locations 1
United States (1)
Beth Israel Deaconess Medical Center
Boston , Massachusetts
Technical details
Status
Active (not recruiting)
Study type
OBSERVATIONAL
Sex
Male and female
Minimum age
40 Years
Maximum age
100 Years
Healthy volunteers
No
Start date
21.04.2023
Completion date
01.09.2026
Registry ID
NCT05973331
Source
clinicaltrials.gov
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