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Active, Not Recruiting

NCT Number: NCT05973331

Prospective Validation of an EHR-based Pancreatic Cancer Risk Model

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pancreatic Adenocarcinoma Predictive Cancer Model

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

About this study

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:

  • AUROC, sensitivity, specificity, PPV/NPV for assessing discrimination
  • Calibration: for assessing the accuracy of estimates, based on the estimated to observed number of events

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pancreatic Cancer Risk Model (PRISM)

Other

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

Primary outcomes

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

    Time frame: 6 months from index date

    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.

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

    Time frame: at 1 year

    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.

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

    Time frame: at 2 years

    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.

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

    Time frame: at 3 years

    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.

  5. Calibration of PRISM for all groups stratified

    Time frame: 6 months from index date

    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.

  6. Calibration of PRISM for all groups stratified

    Time frame: at 1 year

    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.

  7. Calibration of PRISM for all groups stratified

    Time frame: at 2 years

    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.

  8. Calibration of PRISM for all groups stratified

    Time frame: at 3 years

    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.

  9. PRISM performance metrics of high-risk group for direct screening

    Time frame: 6 months from index date

    To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.

  10. PRISM performance metrics of high-risk group for direct screening

    Time frame: at 1 year

    To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.

  11. PRISM performance metrics of high-risk group for direct screening

    Time frame: at 2 years

    To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.

  12. PRISM performance metrics of high-risk group for direct screening

    Time frame: at 3 years

    To evaluate sensitivity, specificity, PPV, and SIR for patients identified as high-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined based on Standardized Incidence Ratio of 5 or greater. The absolute one-year risk thresholds are 0.1834% for PrismNN and 0.2048% risk for PrismLR. SIR 5 or greater was chosen because it is comparable to the current screening inclusion threshold for individuals with an inherited predisposition.

  13. PRISM performance metrics of medium-risk group for biomarker testing

    Time frame: 6 months from index date

    To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.

  14. PRISM performance metrics of medium-risk group for biomarker testing

    Time frame: at 1 year

    To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.

  15. PRISM performance metrics of medium-risk group for biomarker testing

    Time frame: at 2 years

    To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.

  16. PRISM performance metrics of medium-risk group for biomarker testing

    Time frame: at 3 years

    To evaluate sensitivity, specificity, PPV, and SIR for patients identified as medium-risk by PRISM. Numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location. Risk threshold determined by specificity 85%, with sensitivity around 46%. The absolute one-year risk thresholds are 0.0574% for PrismNN and 0.0564% for PrismLR. Prism operates as a tiered system for identifying individuals in need of screening with this lower risk threshold.

Secondary outcomes

  1. Timing of incident PDAC occurrence

    Time frame: 6 months from index date

    To evaluate how long in advance before PDAC occurrence should be expected for PRISM models to make high-risk predictions. Distribution plots of the date of PDAC incidence for high/medium-risk groups (defined in Outcome 3 and Outcome 4) will be created.

  2. Timing of incident PDAC occurrence

    Time frame: at 1 year

    To evaluate how long in advance before PDAC occurrence should be expected for PRISM models to make high-risk predictions. Distribution plots of the date of PDAC incidence for high/medium-risk groups (defined in Outcome 3 and Outcome 4) will be created.

  3. Timing of incident PDAC occurrence

    Time frame: at 2 years

    To evaluate how long in advance before PDAC occurrence should be expected for PRISM models to make high-risk predictions. Distribution plots of the date of PDAC incidence for high/medium-risk groups (defined in Outcome 3 and Outcome 4) will be created.

  4. Timing of incident PDAC occurrence

    Time frame: at 3 years

    To evaluate how long in advance before PDAC occurrence should be expected for PRISM models to make high-risk predictions. Distribution plots of the date of PDAC incidence for high/medium-risk groups (defined in Outcome 3 and Outcome 4) will be created.

  5. Tumor stage at PDAC diagnosis

    Time frame: 6 months from index date

    stage at diagnosis per tumor registry/pathology report

  6. Tumor stage at PDAC diagnosis

    Time frame: at 1 year

    stage at diagnosis per tumor registry/pathology report

  7. Tumor stage at PDAC diagnosis

    Time frame: at 2 years

    stage at diagnosis per tumor registry/pathology report

  8. Tumor stage at PDAC diagnosis

    Time frame: at 3 years

    stage at diagnosis per tumor registry/pathology report

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Massachusetts Institute of Technology
  • TriNetX, LLC

Registry information

Official study title

Prospective Validation of an EHR-based Model to Predict Pancreatic Cancer Risk Using Multicenter US Data

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 2, 2023
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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