- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05973331
Prospective Validation of an EHR-based Pancreatic Cancer Risk Model
Prospective Validation of an EHR-based Model to Predict Pancreatic Cancer Risk Using Multicenter US Data
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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:
- AUROC, sensitivity, specificity, PPV/NPV for assessing discrimination
- Calibration: for assessing the accuracy of estimates, based on the estimated to observed number of events
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Beth Israel Deaconess Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months from index date
|
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.
|
at 1 year
|
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.
|
at 2 years
|
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.
|
at 3 years
|
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 months from index date
|
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.
|
at 1 year
|
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.
|
at 2 years
|
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.
|
at 3 years
|
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.
|
6 months from index date
|
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.
|
at 1 year
|
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.
|
at 2 years
|
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.
|
at 3 years
|
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.
|
6 months from index date
|
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.
|
at 1 year
|
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.
|
at 2 years
|
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.
|
at 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months from index date
|
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.
|
at 1 year
|
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.
|
at 2 years
|
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.
|
at 3 years
|
Tumor stage at PDAC diagnosis
Time Frame: 6 months from index date
|
stage at diagnosis per tumor registry/pathology report
|
6 months from index date
|
Tumor stage at PDAC diagnosis
Time Frame: at 1 year
|
stage at diagnosis per tumor registry/pathology report
|
at 1 year
|
Tumor stage at PDAC diagnosis
Time Frame: at 2 years
|
stage at diagnosis per tumor registry/pathology report
|
at 2 years
|
Tumor stage at PDAC diagnosis
Time Frame: at 3 years
|
stage at diagnosis per tumor registry/pathology report
|
at 3 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Limor Appelbaum, MD, Beth Israel Deaconess Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023Trial
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pancreatic Adenocarcinoma
-
Fudan UniversityUnknownStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
-
Roswell Park Cancer InstituteNot yet recruitingStage II Pancreatic Cancer AJCC v8 | Stage III Pancreatic Cancer AJCC v8 | Stage IV Pancreatic Cancer AJCC v8 | Metastatic Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal Adenocarcinoma | Advanced Pancreatic Ductal Adenocarcinoma | Unresectable Pancreatic Ductal Adenocarcinoma and other conditionsUnited States
-
Xian-Jun YuCompletedStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
-
Xian-Jun YuCompletedStage IA Pancreatic Adenocarcinoma | Stage IB Pancreatic Adenocarcinoma | Stage IIA Pancreatic Adenocarcinoma | Stage IIB Pancreatic AdenocarcinomaChina
-
Scandion Oncology A/SAlcedis GmbHRecruitingMetastatic Pancreatic Adenocarcinoma | Locally Advanced Pancreatic Adenocarcinoma | Inoperable Disease | Localized Pancreatic AdenocarcinomaDenmark, Germany
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Cancer Metastatic | Pancreatic Cancer Stage IV | Metastatic Pancreatic Carcinoma | Metastatic Pancreatic Adenocarcinoma | Pancreatic Carcinoma | Metastatic Pancreatic Cancer | Pancreatic Cancer Non-resectable | Metastatic Pancreatic Ductal Adenocarcinoma | Pancreatic Carcinoma... and other conditionsUnited States
-
Lawson Health Research InstituteLondon Health Sciences FoundationNot yet recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Adenocarcinoma
-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingPancreas Adenocarcinoma | Locally Advanced Pancreatic Adenocarcinoma | Borderline Resectable Pancreatic AdenocarcinomaUnited States
-
Jean-Luc Van LaethemCelgene CorporationCompletedPancreatic Adenocarcinoma Resectable | Pancreatic Adenocarcinoma Metastatic | Pancreatic Adenocarcinoma Locally AdvancedBelgium
Clinical Trials on Pancreatic Cancer Risk Model (PRISM)
-
Hoag Memorial Hospital PresbyterianSuspended
-
Chung Shan Medical UniversityMinistry of Health and Welfare, TaiwanRecruiting
-
University of ArkansasWithdrawnPancreatic Neoplasms | Colorectal Neoplasms, Hereditary Nonpolyposis | BRCA1 Gene Mutation | BRCA2 Gene Mutation | Hereditary Pancreatitis | Ataxia Telangiectasia | Peutz-Jegher's Syndrome | Familial Atypical Mole-Malignant Melanoma SyndromeUnited States
-
Zhejiang UniversityCompleted
-
ClearNote HealthNot yet recruitingPancreatic CancerUnited States
-
Zhejiang UniversityFudan UniversityUnknownLiver Transplantation | Hepatocellular Carcinoma | Magnetic Resonance Imaging
-
Zhejiang UniversityUnknown
-
First Affiliated Hospital Xi'an Jiaotong UniversityWest China Hospital; Health Science Center of Xi'an Jiaotong UniversityRecruiting
-
Istituto Auxologico ItalianoRecruitingCardiovascular Diseases | Cardiomyopathies | Ischemic Heart Disease | Sudden Cardiac Death Due to Cardiac ArrhythmiaItaly
-
University of IbadanUniversity College Hospital, Ibadan; Obafemi Awolowo University Teaching Hospital and other collaboratorsCompletedBreast Cancer | Health Behavior | Health Knowledge, Attitudes, Practice | Health Care Utilization | Risk Reduction BehaviorNigeria