Prospective Validation of an EHR-based Pancreatic Cancer Risk Model

Brief summary public domain (ClinicalTrials.gov)

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.

Detailed description public domain (ClinicalTrials.gov)

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

Intervention public domain (ClinicalTrials.gov)

Other: Pancreatic Cancer Risk Model (PRISM). A neural network model (PrismNN) and a logistic regression model (PrismLR) that use routinely collected EHR data to stratify individuals from the general population into PDAC risk groups

Arm public domain (ClinicalTrials.gov)

prospective general opulation cohort (): Males and females age \>= 40 years, without a personal history of PDAC or current PDAC, with at least 2 clinical encounters to the HCO within the year prior to the study start date.

Primary outcome public domain (ClinicalTrials.gov)

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified. To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Time frame: 6 months from index date.

Primary outcome public domain (ClinicalTrials.gov)

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified. To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Time frame: at 1 year.

Primary outcome public domain (ClinicalTrials.gov)

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified. To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Time frame: at 2 years.

Primary outcome public domain (ClinicalTrials.gov)

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified. To assess the discriminatory performance of PRISM for prospective identification of high-risk individuals for PDAC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Time frame: at 3 years.

Primary outcome public domain (ClinicalTrials.gov)

Calibration of PRISM for all groups stratified. To access how well the risk prediction by PRISM aligns with observed risk without recalibration. Calibration plots will be created for the whole population and groups stratified by age, sex, race, and geographical location. Time frame: 6 months from index date.

Secondary outcome public domain (ClinicalTrials.gov)

Timing of incident PDAC occurrence. Time frame: 6 months from index date.

Secondary outcome public domain (ClinicalTrials.gov)

Timing of incident PDAC occurrence. Time frame: at 1 year.

Secondary outcome public domain (ClinicalTrials.gov)

Timing of incident PDAC occurrence. Time frame: at 2 years.

Secondary outcome public domain (ClinicalTrials.gov)

Timing of incident PDAC occurrence. Time frame: at 3 years.

Secondary outcome public domain (ClinicalTrials.gov)

Tumor stage at PDAC diagnosis. Time frame: 6 months from index date.

Secondary outcome public domain (ClinicalTrials.gov)

Tumor stage at PDAC diagnosis. Time frame: at 1 year.

Eligibility public domain (ClinicalTrials.gov)

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.

Enrollment public domain (ClinicalTrials.gov)

Enrollment: 6134060 participants (actual).