RecruitingOBSERVATIONAL

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

This study, called PROSPECT, is searching for new 'biomarkers' - tiny signals in the body that can help doctors predict the health of patients with severe liver disease (cirrhosis) after they leave hospital. Many patients with cirrhosis have serious complications that require hospitalisation. The aim is to find better ways to understand how the disease affects individuals, so doctors can provide more personalised care and improve recovery and survival rates. By analysing blood samples and other information, researchers hope to identify these key markers. This work is part of a larger European project called DECISION, focused on reducing deaths from this serious condition.

At a glance

Status

Recruiting

Sponsor

European Foundation for Study of Chronic Liver Failure

Enrolment target

189

Start

01 Mar 2025

Estimated completion

30 Sep 2026

Liver Cirrhosis Decompensated Cirrhosis of Liver

What is this study about?

This research, known as the PROSPECT study, is all about finding better ways to predict how patients with severe liver cirrhosis will fare after being in hospital for a serious complication. Cirrhosis is a long-term liver disease, and sometimes it can get much worse, leading to hospitalisation. Doctors want to be able to better understand what happens in the body during these times to improve care.

The study is looking for what scientists call 'biomarkers'. Think of these like little clues in your body, such as specific molecules in your blood, that can tell doctors important information. By finding new and effective biomarkers, medical teams hope to get a clearer picture of each patient's individual situation, helping them to predict who might be at higher risk and who might recover better. This understanding is key to developing more tailored treatments and care plans, ultimately aiming to reduce serious health problems and improve lives.

This study is part of a bigger European project called DECISION, which is trying to understand severe liver disease at a very detailed level. By looking closely at many different biological signals, researchers are working to find key indicators that can guide treatment. The overall goal is to significantly reduce the number of deaths from this condition by finding the best possible ways to help each patient.

Key takeaways

This study aims to find new ways to predict health outcomes for severe liver disease patients.
Researchers are looking for 'biomarkers' – natural signals in your body – to help doctors.
Participation involves giving blood samples and health updates over 6 months.
The goal is to improve personalised care and reduce serious complications.
No new medications are involved in this study.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you would need to be between 18 and 80 years old. You must have been admitted to hospital recently because your liver cirrhosis became suddenly worse, for example, if you developed fluid build-up (ascites), confusion (hepatic encephalopathy), or a bacterial infection. Importantly, you should be recovering and expected to leave the hospital within the next 48 hours.

However, there are several reasons why you might not be able to join. For example, if you were admitted for a planned check-up rather than an emergency, or if you have certain types of cancer not related to specific liver conditions. You also couldn't take part if you've recently started specific treatments for hepatitis, have uncontrolled HIV, or severe ongoing alcohol issues that might make it hard to follow the study plan.

Other reasons for not being eligible include if you've had an organ transplant, have a specific device in your liver (like a TIPS), or suffer from severe long-term kidney, heart, or lung disease. If you have a serious illness expected to shorten your life significantly (less than 6 months), severe mental health problems, or are pregnant or breastfeeding, you also wouldn't be able to participate. Finally, if you're unable to give your written permission to join or find it difficult to stick to a study plan, you wouldn't be included.

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 between 18 and 80 years old?
Were you recently admitted to hospital because your liver cirrhosis suddenly got worse?
Are you recovering and expected to leave the hospital within the next 48 hours?
Do you have any serious long-term conditions like severe kidney, heart, or lung disease that could exclude you?
Have you had an organ transplant or specific liver devices (like TIPS)?
Are you able to provide written permission and commit to the study visits?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be enrolled in the study shortly before you're due to leave the hospital. Your involvement in the study will last for 6 months (180 days). During this time, you'll have an initial visit at the hospital where doctors will collect some information about your health and take additional blood samples. After this, there will be two follow-up visits, which can sometimes be done over the phone, where the team will just gather updated information about your health, without needing more blood tests. The blood samples collected will be used to look for the new biomarkers identified within the larger DECISION project, and to understand more about how your body is responding to the disease, such as signs of inflammation.

Potential risks and benefits

Participating in this study might not offer direct benefits to you personally, but the information doctors learn could help improve care for many future patients with liver cirrhosis. The main 'risk' would be the discomfort of having blood samples taken, similar to any routine blood test. This study does not involve any new medications. You have the right to withdraw from the study at any time without giving a reason, and this decision will not affect your usual medical care.

Locations (9)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hospital Beaujon
Verified postcode
Clichy, France· Recruiting
University Hospital, Aachen
Verified postcode
Aachen, Germany· Recruiting
Universitätsklinikum Münster
Verified postcode
Münster, Germany· Recruiting
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di S.Orsola
Verified postcode
Bologna, Italy· Recruiting
A.O.U. Città della Salute e della Scienza di Torino
Verified postcode
Torino, Italy· Recruiting
Hospital Universitari Vall d'Hebron Research Institute
Verified postcode
Barcelona, Spain· Recruiting
Hospital Clinic de Barcelona
Verified postcode
Barcelona, Spain· Recruiting
Hospital Universitario Ramon y Cajal
Verified postcode
Madrid, Spain· Recruiting
Royal Free Hospital
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is liver cirrhosis?

Liver cirrhosis is a serious, long-term scarring of the liver which can stop it from working properly. It can have various causes, like long-term alcohol use or hepatitis.

What are biomarkers?

Biomarkers are like natural signals or clues found in your body, for example, in your blood, that can tell doctors important things about your health or how a disease is progressing.

Will taking part involve new medication?

No, this study does not involve testing any new medications. It's focused on gathering information through blood samples and health updates.

How long will I be in the study?

If you join, your participation in the study will last for a total of 6 months (180 days) from when you enrol.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason, and this will not affect your medical care.

How to find out more

Anna Bosch

anna.bosch@efclif.com +34 93 227 14 03 Official trial record

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