Clinical trial · Interventional
Risk Stratification of Hepatocarcinogenesis Using a Deep Learning Based Clinical, Biological and Ultrasound Model in High-risk Patients
- 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)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Liver Disease | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Video acquisition | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High risk group
- description
- Patients with hepatocellular carcinoma greater than 1 cm in size. All patients from an ultrasound screening programme who have been diagnosed with a nodule larger than 1 cm and referred to our centres will be included in this group. They will then be excluded of this group if the diagnosis of hepatocellular carcinoma is not retained according to the radiological or histological reference diagnostic standards (gold standard).
- interventionNames
- Other: Video acquisition
- type
- EXPERIMENTAL
- label
- Low risk group
- description
- Patients without hepatocellular carcinoma. A 1-year interval ultrasound will be performed to confirm the absence of new nodule in the year following inclusion.
- interventionNames
- Other: Video acquisition
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (14)
- BACKGROUNDCadier B, Bulsei J, Nahon P, Seror O, Laurent A, Rosa I, Layese R, Costentin C, Cagnot C, Durand-Zaleski I, Chevreul K; ANRS CO12 CirVir and CHANGH groups. Early detection and curative treatment of hepatocellular carcinoma: A cost-effectiveness analysis in France and in the United States. Hepatology. 2017 Apr;65(4):1237-1248. doi: 10.1002/hep.28961. Epub 2017 Feb 8. PMID 28176349
- BACKGROUNDCostentin CE, Layese R, Bourcier V, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Riachi G, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle C, Dao T, Thabut D, Pilette C, Silvain C, Christidis C, Nguyen-Khac E, Bernard-Chabert B, Zucman D, Di Martino V, Sutton A, Letouze E, Imbeaud S, Zucman-Rossi J, Audureau E, Roudot-Thoraval F, Nahon P; ANRS CO12 CirVir Group. Compliance With Hepatocellular Carcinoma Surveillance Guidelines Associated With Increased Lead-Time Adjusted Survival of Patients With Compensated Viral Cirrhosis: A Multi-Center Cohort Study. Gastroenterology. 2018 Aug;155(2):431-442.e10. doi: 10.1053/j.gastro.2018.04.027. Epub 2018 May 3. PMID 29729258
- BACKGROUNDIoannou GN, Green P, Kerr KF, Berry K. Models estimating risk of hepatocellular carcinoma in patients with alcohol or NAFLD-related cirrhosis for risk stratification. J Hepatol. 2019 Sep;71(3):523-533. doi: 10.1016/j.jhep.2019.05.008. Epub 2019 May 28. PMID 31145929
- BACKGROUNDAudureau E, Carrat F, Layese R, Cagnot C, Asselah T, Guyader D, Larrey D, De Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Riachi G, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Chazouilleres O, Mallat A, Grange JD, Attali P, d'Alteroche L, Wartelle C, Dao T, Thabut D, Pilette C, Silvain C, Christidis C, Nguyen-Khac E, Bernard-Chabert B, Zucman D, Di Martino V, Sutton A, Pol S, Nahon P; ANRS CO12 CirVir group. Personalized surveillance for hepatocellular carcinoma in cirrhosis - using machine learning adapted to HCV status. J Hepatol. 2020 Dec;73(6):1434-1445. doi: 10.1016/j.jhep.2020.05.052. Epub 2020 Jun 29. PMID 32615276