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Prospective Validation of an EHR-based Pancreatic Cancer Risk Model

StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Completion pushed from Sep 2026 to Apr 2028 Primary completion date changed from estimate of Jul 2026 to Jun 8, 2026 · Secondary endpoints: 8 to 9 · Eligibility criteria expanded, about 4 words · 1 more Show 4 more changesShow less
    • Primary completion date changed from estimate of Jul 2026 to Jun 8, 2026
    • Secondary endpoints: 8 to 9
    • Eligibility criteria expanded, about 4 words
    • Study description expanded, about 2 words
  2. Minor Collaborators: 1 to 2v4 See this version in full on ClinicalTrials.gov ↗
  3. Minor Start date: Jul 17, 2023 to Apr 21, 2023 Collaborators: 2 to 1v3 Show 1 more changeShow less
  4. Minor Re-verified, no change to tracked fieldsv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05973331
Lead Sponsor Beth Israel Deaconess Medical Center
Collaborators: Massachusetts Institute of Technology, TriNetX, LLC
Conditions Pancreatic Adenocarcinoma, Predictive Cancer Model
Enrollment 6,134,060 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov