CompletedNot Applicable

Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients

France400 participantsStarted 2021-09-01

Plain-language summary

By 2030, hepatocellular carcinoma (HCC) will become the second leading cause of cancer-related death, accounting for more than one million deaths per year according to the World Health Organization. To this date, screening for hepatocellular carcinoma in France remains uniform for all patients, based solely on a liver ultrasound every 6 months. This strategy has three main limitations: lack of personalisation, low compliance, relatively poor performance of the ultrasound. Risk stratification models have been developed for chronic hepatitis C, alcoholic cirrhosis and non-alcoholic steatohepatitis (NASH) including clinical and biological parameters but no analysis of the liver parenchyma which is the physiopathological substrate of hepatocarcinogenesis. The advent of new artificial intelligence techniques could revolutionize the approach and lead to a personalised radiological screening strategy. Deep learning, a subclass of machine learning, is a popular area of research that can help humans performing certain tasks by automatically identifying new image features not defined by humans. The hypothesis of this study is that the non-tumor cirrhotic liver parenchyma is rich in structural information reflecting the severity of the hepatopathy, its carcinological risk and the process of hepatocarcinogenesis. Its analysis combined with clinical and biological data, which have already been studied to stratify the risk of hepatocarcinogenesis, will allow to define a very high-risk population, particularly in the context of Hepatitis C Virus (HCV) eradication and Hepatitis B Virus (HBV) control. Consequently, this study proposes to design prospectively a deep learning model for stratification of the risk of hepatocarcinogenesis by including clinical, biological and radiological ultrasound parameters.

Who can participate

Age range

18 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.

Inclusion Criteria: * Men or women over 18 years of age. * Patients referred by their hepatologist within the framework of ultrasound screening according to the EASL hepato-cellular carcinoma screening recommendations. * Non-cirrhotic F3 hepatopathy of any cause according to an individual assessment of the risk of hepatocarcinoma. * Cirrhosis from any cause, non viral or virologically cured (HCV) or controlled (HBV). * Patient with hepatopathy proven by histological evidence or confirmed by an expert committee based on clinical, biological, ultrasound (hepato-cellular insufficiency, portal hypertension) and elastographic criteria. * Patient able to receive and understand the information relating to the study and to give his/her written informed consent. * Patient affiliated to the French social security system. Exclusion Criteria: * History of hepatocarcinoma * Patient with non-cirrhotic viral B hepatopathy or uncontrolled (HBV) or uncured (HCV) viral cirrhosis. * Patient under protection of justice, guardianship or trusteeship. * Patient in a situation of social fragility. * Patient subject to legal protection or unable to express consent

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

Stratification of the risk of hepatocarcinogenesis in high-risk patients by a deep learning-based cross-analysis.

Timeframe: 12 months

Trial details

NCT IDNCT04802954

SponsorIHU Strasbourg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-14

View on ClinicalTrials.gov More Hepatocellular Carcinoma trials