Clinical trial · Observational
Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models
Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models on Multicenter EHR 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 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Predictive Cancer Model | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Liver Risk Computation Model (LIRIC) | Other | — | UNRESOLVED |
| Liver Risk Computation Model (LIRIC)_cirrhosis | Other | — | UNRESOLVED |
| Liver Risk Computation Model (LIRIC)_no_cirrhosis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- prospective general population cohort
- description
- Males and females age \>= 40 years, without a personal history of HCC or current HCC and at least two clinical visits to their HCO, within the last year, before the study start date.
- interventionNames
- Other: Liver Risk Computation Model (LIRIC)
- label
- Prospective cirrhosis population cohort
- description
- Males and females age \>= 40 years, with liver cirrhosis and without a personal history of HCC or current HCC, that have at least two clinical visits to their HCO, within the last year, before the study start date.
- interventionNames
- Other: Liver Risk Computation Model (LIRIC)_cirrhosis
- label
- Prospective no_cirrhosis population cohort
- description
- Males and females age \>= 40 years, without a personal history of HCC or current HCC and without a diagnosis of liver cirrhosis, that have at least two clinical visits to their HCO, within the last year, before the study start date.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available