Nerve and heart activity in hepatocellular carcinoma (HCC)
Involvement of the Autonomic Nervous System in Hepatocellular Carcinoma (HCC): a Pilot Psycho-behavioral and Neurophysiological Study
NA · Hospices Civils de Lyon · NCT07393074
This project will test whether measuring autonomic nervous system signals—such as heart rate patterns, sensory‑response tests, and liver biopsy markers—can help detect or better characterize HCC in adults with compensated cirrhosis who are having a liver biopsy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon (other) |
| Locations | 1 site (Lyon) |
| Trial ID | NCT07393074 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults over 18 with compensated (Child‑Pugh A) cirrhosis who can read and speak French, are covered by the French social security system, and are scheduled for a clinical liver biopsy are the intended participants.
Not a fit: Patients with decompensated cirrhosis (Child‑Pugh B/C), advanced HCC, inability to undergo ECG or biopsy procedures, or who do not meet the French‑language or social‑security requirements are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could provide a noninvasive adjunct (ECG and ANS markers) to help detect HCC earlier or better stratify risk in patients with cirrhosis.
How similar studies have performed: Some prior research links autonomic measures like heart rate variability to cancer prognosis, but using ANS signals specifically to detect early HCC is largely novel and not yet validated.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Lyon
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hepato Cellular Carcinoma, Cirrhosis, Autonomic Nervous System, Central Nervous System, HCC, cirrhosis, ANS, NRS