Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115, United States
NCT Number: NCT06140823
The goal of this prospective observational cohort study is to validate previously developed Hepatocellular Carcinoma (HCC) risk prediction algorithms, the Liver Risk Computation (LIRIC) models, which are based on electronic health records.
The main questions it aims to answer are:
* Will our retrospectively developed general population LIRIC models, developed on routine EHR data, perform similarly when prospectively validated, and reliably and accurately predict HCC in real-time? * What is the average time from model deployment and risk prediction, to the date of HCC development and what is the stage of HCC 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.
This study is active but is not currently recruiting participants.
Notify Me40 year–100 year
All sexes
Observational
Boston, Massachusetts, 02115, United States
The investigators will conduct a prospective observational cohort study, separately deploying three separate LIRIC models (the general population, cirrhosis, and no_cirrhosis models) on retrospective de-identified EHR data of 44 HCOs in the USA, using the TriNetX federated network platform. LIRIC will generate a risk score for each individual. All risk-stratified individuals will be prospectively, electronically followed for up to 3-years to assess the primary end-point of HCC development. At the end of this period, model discrimination will be assessed, using the following metrics: AUROC, sensitivity, specificity, PPV/NPV. Risk scores generated by the model will be divided into quantiles. For each quantile, the investigators will evaluate the following: number of individuals in each quantile, number of HCC cases, PPV, NNS, SIR. Model calibration will be used for assessing the accuracy of estimates, based on the estimated to observed number of events. The model will dynamically re-evaluate all individual data every 6 months, re-classifying individuals (as needed).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
The investigators will utilize the following criteria for all 3 models:
Inclusion criteria
Exclusion criteria
A neural network model (LIRIC-NN) and a logistic regression model (LIRIC-LR) that use routinely collected EHR data to stratify individuals into HCC risk groups for the general population
A neural network model (LIRIC-NN) and a logistic regression model (LIRIC-LR) that use routinely collected EHR data to stratify individuals into HCC risk groups for the population with liver cirrhosis
neural network model (LIRIC-NN) and a logistic regression model (LIRIC-LR) that use routinely collected EHR data to stratify individuals into HCC risk groups for the population without liver cirrhosis
Time frame: 6 months from index date, at 1 year, 2 years and 3 years
To assess the discriminatory performance of LIRIC for prospective identification of high-risk individuals for HCC development. ROCs and AUROC numbers will be calculated for the whole population and groups stratified by age, sex, race, and geographical location.
Time frame: 6 months from index date, at 1 year, 2 years and 3 years
To assess how well the risk prediction by LIRIC 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.
Time frame: 6 months from index date, at 1 year, 2 years and 3 years
To evaluate the sensitivity, specificity, number of individuals/number of HCC cases, PPV, NNS in each predicted risk quantile for multiple risk thresholds
Time frame: 6 months from index date, at 1 year, 2 years and 3 years
To evaluate how long in advance before HCC occurrence should be expected for LIRIC models to make high-risk predictions based on different thresholds for high-risk. Distribution plots of the date of HCC incidence for multiple risk thresholds will be created.
Time frame: 6 months from index date, at 1 year, 2 years and 3 years
TNM staging at HCC diagnosis
Beth Israel Deaconess Medical Center
Other
Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models on Multicenter EHR Data
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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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