RecruitingNAINTERVENTIONAL

PSYLIVER-PILOTE: Involvement of the Autonomic Nervous System in Hepatocellular Carcinoma (HCC)

This study, called PSYLIVER-PILOTE, is exploring the connection between the body's unconscious control system, known as the Autonomic Nervous System (ANS), and liver cancer (Hepatocellular Carcinoma or HCC). Liver cancer is a serious condition, especially when it develops from long-term liver damage (cirrhosis). Current ways to find HCC early aren't always effective enough. Researchers believe the ANS, which controls things like heart rate and digestion, might play a key role in how HCC develops and progresses. By measuring ANS activity and looking at how it relates to behaviour and emotions, this study hopes to discover new warning signs for HCC and open doors to more tailored treatments. This could significantly improve outcomes for people at risk of liver cancer.

At a glance

Status

Recruiting

Phase

Sponsor

Hospices Civils de Lyon

Enrolment target

100

Start

17 Apr 2026

Estimated completion

17 Apr 2028

Hepato Cellular Carcinoma Cirrhosis Autonomic Nervous System Central Nervous System

What is this study about?

This study is investigating a type of liver cancer called Hepatocellular Carcinoma (HCC), which often develops in people with long-term liver problems like cirrhosis. HCC is a very serious condition, and finding it early is crucial for successful treatment. Unfortunately, current screening methods, like ultrasound scans, don't always pick up small tumours. This means we urgently need better ways to predict and detect HCC early so that people can get the help they need quicker.

Researchers are particularly interested in the Autonomic Nervous System (ANS). Think of the ANS as the body's automatic pilot – it controls all the things you don't consciously think about, like your heart beating, your breathing, and your digestion. It also plays a role in how your body responds to stress and emotions. The ANS has two main parts: one that revs things up (fight or flight) and one that calms things down (rest and digest). We know that the ANS is involved in many body processes, and there's growing evidence that it might also influence how cancers develop and grow, including in the liver. Understanding this link could help us find new ways to spot HCC earlier.

In this study, called PSYLIVER-PILOTE, we will be looking at how the ANS works in people with cirrhosis. We'll measure ANS activity using various methods, including checking heart activity and using questionnaires about mood and behaviour. The aim is to see if there are specific patterns in ANS activity that are linked to HCC. By identifying these patterns, we hope to develop new ‘markers’ – essentially, early warning signs – that could help doctors detect HCC before it becomes advanced. This research could lead to more personalised ways to prevent, detect, and treat liver cancer in the future, ultimately improving the health and lives of people affected by this condition.

Key takeaways

This study explores how the body's automatic control system (ANS) might impact liver cancer (HCC).
It aims to find new, earlier ways to detect HCC in people with cirrhosis.
Participation involves non-invasive measurements, questionnaires, and a one-night heart monitor at home.
If you're having a routine liver biopsy, a tiny sample might also be analysed.
This research could lead to more personalised treatments for liver cancer.
Your medical care will not be affected regardless of your decision to participate.

Who may be eligible?

To join this study, you need to be over 18 years old and have permission from your doctor. You'll also need to be fluent in French to understand and take part in the conversations and surveys.

There are two main groups of people we are looking for. Group A includes those who have compensated cirrhosis (a milder form of liver scarring) and are already scheduled for a liver biopsy as part of their regular care, either to confirm their cirrhosis or to find out what's causing their liver problems. Group B is for individuals who also have compensated cirrhosis and are scheduled for a liver biopsy because their doctors suspect they might have HCC based on scans.

However, some people won't be able to join. This includes anyone who has had any type of cancer before, pregnant or breastfeeding women, or those under legal protection like guardianship. If you have certain medical conditions like psychotic disorders, degenerative brain conditions (like Parkinson's disease), or use specific heart rhythm medications or certain psychiatric drugs that affect the ANS, you unfortunately won't be able to participate. You also can't take part if you have electronic implants like pacemakers or if a liver biopsy isn't safe for you due to other health issues.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you speak and read French well enough for conversations and surveys?
Do you have a diagnosis of compensated cirrhosis?
Are you scheduled for a liver biopsy as part of your regular medical care?
Have you *never* had cancer before (including liver cancer)?
Do you *not* have a pacemaker, cochlear implant, or similar electronic device?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be asked to complete several activities. We will measure the activity of your Autonomic Nervous System (ANS) both when you are resting and when you are experiencing certain harmless sensations. You will also fill out some questionnaires to tell us about your thoughts, feelings, and behaviours.

You will wear a small device at home for one night to record your heart's electrical activity (an ECG). This will help us understand your heart's rhythm and how your ANS is working while you sleep. Additionally, if you are having a liver biopsy as part of your regular medical care, a small sample from that biopsy will be used for extra analysis to look at ANS activity within your liver.

Throughout the study, we will also calculate a score called the NRS score. The total duration of your participation in the study largely depends on when your routine liver biopsy and follow-up clinical appointments occur, but data collection will primarily happen around that biopsy.

Potential risks and benefits

Taking part in this study may offer you the benefit of contributing to new knowledge about liver cancer and helping to develop better early detection methods and treatments for others in the future. There are no direct medical benefits for you from participating. The procedures, such as the ANS measurements and questionnaires, are generally considered low risk. The nocturnal heart activity recording is non-invasive and done at home. The study will also use a small part of a liver biopsy that you would be having anyway as part of your standard medical care, so you won't undergo any extra invasive procedures specifically for the study. As with any study, there's always a small chance of unforeseen discomfort, but every effort will be made to minimise this. Your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (1)

Hôpital de la Croix Rousse
Verified postcode
Lyon, France· Recruiting

Common questions

What is the Autonomic Nervous System (ANS)?

The ANS is your body’s automatic control system, regulating unconscious bodily functions like heart rate, breathing, and digestion, and how you react to stress.

Why are you studying the ANS in liver cancer?

We believe the ANS might play a hidden role in how liver cancer develops. Understanding this could help us find new ways to detect it earlier and create more effective, personalised treatments.

Will I have to take any new medications for this study?

No, this study does not involve taking any new medications. We are focused on measuring natural body functions and observations, not giving new treatments.

What is a liver biopsy and will I have one for the study?

A liver biopsy is a procedure where a tiny piece of your liver is taken for examination. You will only have one if your doctor has already decided you need it as part of your usual medical care, not specifically for this study.

Is my personal information kept private?

Yes, all your personal information and study results will be kept strictly confidential and anonymous to protect your privacy.

How to find out more

Dr VILLERET François

francois.villeret@chu-lyon.fr +33 4 26 73 27 33 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.