Nerve and heart activity in hepatocellular carcinoma (HCC)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This single-center interventional protocol at Hôpital de la Croix Rousse (Lyon) records autonomic nervous system (ANS) activity at rest and during sensory stimulation, collects self‑reported psycho‑behavioral questionnaires, and obtains nocturnal ECG recordings at home to calculate NRS and other ANS metrics. A portion of the liver biopsy taken as part of routine care will be analyzed for intrahepatic markers of ANS activity, with optional biobanking of samples. The team will correlate peripheral and intrahepatic ANS measurements with clinical and imaging data to explore whether these signals associate with presence or early features of HCC. The goal is to identify noninvasive ANS signatures that could complement current ultrasound screening in cirrhotic patients.

Why it matters

Who can join: the full rules

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.)

Where it's running

• Hôpital de la Croix Rousse
  Lyon, France Recruiting

Study contacts

• Study coordinator: Dr VILLERET François
• Email: francois.villeret@chu-lyon.fr
• Phone: +33 4 26 73 27 33

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.