Active — Not RecruitingNot Applicable

Prospective Validation of Liver Cancer Risk Computation (LIRIC) Models

United States6,000,000 participantsStarted 2023-04-01

Plain-language 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.

Who can participate

Age range

40 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the receiver operating characteristic curve (AUROC) of LIRIC for all groups stratified

Timeframe: 6 months from index date, at 1 year, 2 years and 3 years

Calibration of LIRIC for all groups stratified

Timeframe: 6 months from index date, at 1 year, 2 years and 3 years

Performance metrics for LIRIC model risk quantiles

Timeframe: 6 months from index date, at 1 year, 2 years and 3 years

Trial details

NCT IDNCT06140823

SponsorBeth Israel Deaconess Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03-31

View on ClinicalTrials.gov More Predictive Cancer Model trials

Plain-language summary

Who can participate

Age range

40 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Area under the receiver operating characteristic curve (AUROC) of LIRIC for all groups stratified

Timeframe: 6 months from index date, at 1 year, 2 years and 3 years

Calibration of LIRIC for all groups stratified

Timeframe: 6 months from index date, at 1 year, 2 years and 3 years

Performance metrics for LIRIC model risk quantiles

Timeframe: 6 months from index date, at 1 year, 2 years and 3 years