Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Predictive Cancer Model | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreatic Cancer Risk Model (PRISM) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- prospective general opulation cohort
- description
- 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.
- interventionNames
- Other: Pancreatic Cancer Risk Model (PRISM)
Primary outcomes (16)
- measure
- Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
- timeFrame
- 6 months from index date
- description
- 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.
- measure
- Area under the receiver operating characteristic curve (AUROC) of PRISM for all groups stratified
- timeFrame
- at 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available