💬In plain words
What the trial is, and whether it could suit you
Chronic liver diseases affect 1.5 billion people worldwide and can lead to cirrhosis and hepatocellular carcinoma (HCC), which ranks as the third leading cause of cancer-related mortality globally. Despite advances in the treatment of hepatitis B and C, metabolic diseases, and addiction, HCC incidence continues to rise. In France, between 2010 and 2015, the five-year survival rate for liver cancer (90% of which is HCC) was 18% for men and 19% for women. Treatment of HCC is based on the BCLC classification (Barcelona Clinic Liver Cancer), which evaluates both cancer progression and liver function (Child-Pugh classification). Patients at early stages (0 or A) have a survival rate of over 5 years, while those at more advanced stages (C or D) have significantly lower survival rates, highlighting the importance of better early detection tools.
Current screening for HCC in cirrhotic patients
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
Group A:
* Over 18 years of age
* Affiliated with a social security system
* Sufficient command of the French language to hold a conversation and read
* Signature of an informed consent form
* Compensated cirrhosis classified as CHILD-Pugh A with clinical indication for liver biopsy (either for the etiological diagnosis or confirmation of cirrhosis, or for the etiological diagnosis of liver damage)
* Liver biopsy scheduled as part of routine care for a diagnosis of cirrhosis without HCC
Group B:
* Over 18 years of age
* Affiliated with a social security system
* Sufficient command of the French language to hold a conversation and read
* Signature of an informed consent form
* Compensated cirrhosis classified as CHILD-Pugh A with clinical indication for liver biopsy (either for the etiological diagnosis of cirrhosis or its confirmation; or for the etiological diagnosis of liver damage)
* Liver biopsy scheduled as part of routine care for the diagnosis of suspected HCC (based on standard imaging criteria)
Exclusion Criteria:
* Personal history of cancer in the broad sense (including HCC prior to inclusion in the study)
* Pregnant or breastfeeding women
* Adults subject to legal protection measures (guardianship, curatorship)
* Contraindications to trans-parietal liver biopsy: clinical or radiological ascites, coagulation disorders, curative anticoagulation that cannot be suspended, dilation of the bile ducts
* Persons deprived of their liberty by judicial or administrative decision
* Wearers of electronic implants (pacemakers, implantable cardioverter defibrillators, cochlear implants, brain implants, etc.)
* Psychotic disorders
* Degenerative neurological disorders (Parkinson's disease and related disorders, dementia, Korsakoff's syndrome, etc.)
* Antiarrhythmic treatment:
* Class Ia: Disopyramide and Quinidine
* Class Ic: Flecainide and Propafenone
* Neuroleptic psychotropic treatment affecting the ANS (haloperidol, chlorpromazine, olanzapine, clozapine, quetiapine), tricyclic antidepressants (e.g., amitriptyline, amoxapine, clomipramine, etc.)
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