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

NCT04802954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2024-12-18

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Video acquisition

One to three video acquisitions of 10 seconds will be carried out via the intercostal route. Data acquisition will be standardized according to a mandatory protocol and previously recorded in each ultrasound machine (cross shots, harmonic, filter, depth, focal length, mechanical index, etc.).

Sponsors & Collaborators

  • IHU Strasbourg

    lead OTHER

Principal Investigators

  • Jérémy DANA, MD · IHU Strasbourg

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-02-14
Completion
2024-02-14

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04802954 on ClinicalTrials.gov