Active — Not RecruitingNot Applicable

Prospective Validation of an EHR-based Pancreatic Cancer Risk Model

United States6,134,060 participantsStarted 2023-04-21

Plain-language summary

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.

Who can participate

Age range40 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified

Timeframe: 6 months from index date

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified

Timeframe: at 1 year

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified

Timeframe: at 2 years

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified

Timeframe: at 3 years

Calibration of PRISM for all groups stratified

Timeframe: 6 months from index date

Calibration of PRISM for all groups stratified

Timeframe: at 1 year

Calibration of PRISM for all groups stratified

Timeframe: at 2 years

Calibration of PRISM for all groups stratified

Trial details

NCT IDNCT05973331

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-07

View on ClinicalTrials.gov More Pancreatic Adenocarcinoma trials

Plain-language summary

Who can participate

Age range40 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified

Timeframe: 6 months from index date

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified

Timeframe: at 1 year

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified

Timeframe: at 2 years

Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified

Timeframe: at 3 years

Calibration of PRISM for all groups stratified

Timeframe: 6 months from index date

Calibration of PRISM for all groups stratified

Timeframe: at 1 year

Calibration of PRISM for all groups stratified

Timeframe: at 2 years

Calibration of PRISM for all groups stratified