Actively Recruiting
Involvement of the Autonomic Nervous System in Hepatocellular Carcinoma (HCC): a Pilot Psycho-behavioral and Neurophysiological Study
Led by Hospices Civils de Lyon · Updated on 2026-04-29
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Chronic liver diseases impact 1.5 billion people worldwide and can lead to serious conditions like cirrhosis and hepatocellular carcinoma (HCC), a leading cause of cancer deaths globally. Despite advances in treating hepatitis and metabolic diseases, HCC rates continue to rise, and early detection remains challenging due to limited sensitivity of current ultrasound screening. This study explores the role of the autonomic nervous system (ANS) in HCC development, aiming to find new biomarkers for early detection and personalized treatment by analyzing the interaction between tumor cells and their environment through the ANS. The study involves participants with compensated cirrhosis undergoing routine liver biopsy. It includes measuring ANS activity through several methods: tests at rest and during sensory stimulation, self-administered psycho-behavioral questionnaires, nocturnal heart activity monitoring at home via ECG, and analysis of liver biopsy samples for molecular markers. Blood samples may also be collected for biobanking. These procedures help assess both peripheral and central nervous system involvement in HCC. Participants provide medical history and undergo clinical examination and alcohol consumption assessment. During a dedicated hospital visit, ANS activity and psycho-behavioral traits are evaluated. Heart activity is recorded overnight at home using a special kit. Researchers analyze RNA expression of adrenergic and cholinergic receptors in liver tissue and assess various psychological and autonomic measures. The study team monitors these outcomes within six months after inclusion to better understand ANS involvement in HCC and improve early detection strategies.
CONDITIONS
Brief Title
PSYLIVER-PILOTE: Involvement of the Autonomic Nervous System in Hepatocellular Carcinoma (HCC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Affiliated with a social security system
- Sufficient command of the French language to hold a conversation and read
- Signed informed consent form
- Compensated cirrhosis classified as CHILD-Pugh A
- Scheduled liver biopsy as part of routine care for diagnosis of cirrhosis or suspected HCC
You will not qualify if you...
- Personal history of cancer including HCC prior to inclusion
- Pregnant or breastfeeding women
- Adults under legal protection (guardianship or curatorship)
- Contraindications to liver biopsy such as ascites, coagulation disorders, or anticoagulation that cannot be stopped
- Persons deprived of liberty by judicial or administrative decision
- Wearers of electronic implants like pacemakers or brain implants
- Psychotic disorders
- Degenerative neurological disorders (e.g., Parkinson's disease, dementia)
- Use of certain antiarrhythmic medications (Class Ia and Ic)
- Use of neuroleptic psychotropic medications affecting the ANS or tricyclic antidepressants such as amitriptyline or clomipramine
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants undergo a dedicated consultation to perform measurements of autonomic nervous system activity at rest and during sensory stimulation, and complete self-administered psycho-behavioral questionnaires.
1 visit (in-person)
Duration - 1 night
Participants perform an electrocardiographic (ECG) recording of heart activity during one night at home using a provided test kit.
1 home assessment
Duration - Within 6 months after inclusion
Participants have a liver biopsy performed as part of routine care to analyze autonomic nervous system activity at the intrahepatic level for calculating the NRS score.
1 visit (in-person, routine care)
Duration - Within 6 months after inclusion
Participants provide venous blood samples during two visits for optional biocollection.
2 visits (in-person)
Trial Site Locations
Total: 1 location
1
Hôpital de la Croix Rousse
Lyon, France, 69004
Actively Recruiting
Research Team
D
Dr VILLERET François
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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