Prospective Validation of an EHR-based Model to Predict Pancreatic Cancer Risk Using Multicenter US Data
概览
- 阶段
- 不适用
- 干预措施
- Pancreatic Cancer Risk Model (PRISM)
- 疾病 / 适应症
- Pancreatic Adenocarcinoma
- 发起方
- Beth Israel Deaconess Medical Center
- 入组人数
- 6134060
- 试验地点
- 1
- 主要终点
- Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
- 状态
- 进行中（未招募）
- 最后更新
- 10天前
概览
简要总结
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.
详细描述
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
研究者
Limor Appelbaum
Staff Scientist
Beth Israel Deaconess Medical Center
入排标准
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Pancreatic Cancer Risk Model (PRISM)
结局指标
主要结局
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
时间窗: 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.
Calibration of PRISM for all groups stratified
时间窗: 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.
PRISM performance metrics of high-risk group for direct screening
时间窗: 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.
PRISM performance metrics of medium-risk group for biomarker testing
时间窗: 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.
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
时间窗: 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.
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
时间窗: 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.
Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
时间窗: 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.
Calibration of PRISM for all groups stratified
时间窗: 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.
Calibration of PRISM for all groups stratified
时间窗: 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.
Calibration of PRISM for all groups stratified
时间窗: 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.
PRISM performance metrics of high-risk group for direct screening
时间窗: 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.
PRISM performance metrics of high-risk group for direct screening
时间窗: 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.
PRISM performance metrics of high-risk group for direct screening
时间窗: 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.
PRISM performance metrics of medium-risk group for biomarker testing
时间窗: 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.
PRISM performance metrics of medium-risk group for biomarker testing
时间窗: 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.
PRISM performance metrics of medium-risk group for biomarker testing
时间窗: 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.
次要结局
- Timing of incident PDAC occurrence(at 3 years)
- Tumor stage at PDAC diagnosis(at 3 years)
- Timing of incident PDAC occurrence(6 months from index date)
- Timing of incident PDAC occurrence(at 1 year)
- Timing of incident PDAC occurrence(at 2 years)
- Tumor stage at PDAC diagnosis(6 months from index date)
- Tumor stage at PDAC diagnosis(at 1 year)
- Tumor stage at PDAC diagnosis(at 2 years)