Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models

Trial Title: Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models

NCT ID: NCT06140823

Condition: Predictive Cancer Model

Conditions: Official terms:
Liver Neoplasms
Liver Extracts

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Liver Risk Computation Model (LIRIC)
Description: 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
Arm group label: prospective general population cohort

Intervention type: Other
Intervention name: Liver Risk Computation Model (LIRIC)_cirrhosis
Description: 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
Arm group label: Prospective cirrhosis population cohort

Intervention type: Other
Intervention name: Liver Risk Computation Model (LIRIC)_no_cirrhosis
Description: 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
Arm group label: Prospective no_cirrhosis population cohort

Summary: 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.

Detailed description: 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).

Criteria for eligibility:

Study pop:
The cohort will be selected from 44 eligible HCOs comprised of community hospitals, outpatient clinics and academic medical centers from across the US.

Sampling method: Non-Probability Sample
Criteria:
The investigators will utilize the following criteria for all 3 models: Inclusion criteria: - Male and females age ≥40 years from all US HCOs available on the platform - at least at least 2 clinical encounters to the HCO, within the last year, before the study start date Exclusion Criteria: - Personal history of HCC or current HCC (ICD-9: 155.0; ICD-10: C22.0) - Age below 40. The same dataset will be utilized for the non-cirrhosis validation, with exclusion of all cases with cirrhosis (ICD-9: 571.2, 571.5; ICD-10: K70, K70.3, K70.30, K70.31, K74, K74.0, K74.6, K74.60, K74.69). For the cirrhosis validation, the investigators will include only patients with the above cirrhosis codes.

Gender: All

Minimum age: 40 Years

Maximum age: 100 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Beth Israel Deaconess Medical Center

Address:
City: Boston
Zip: 02115
Country: United States

Start date: April 1, 2023

Completion date: March 31, 2027

Lead sponsor:
Agency: Beth Israel Deaconess Medical Center
Agency class: Other

Collaborator:
Agency: Massachusetts Institute of Technology
Agency class: Other

Collaborator:
Agency: TriNetX, LLC
Agency class: Other

Source: Beth Israel Deaconess Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06140823