Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis (PROSPECT)

August 5, 2025 updated by: European Foundation for Study of Chronic Liver Failure

Validation of New Prognostic biomarkerRs in Patients With cirrhOsis diScharged After a hosPitalization Due to acutE deCompensation or acuTe-on-chronic Liver Failure

The study aims to test the effectiveness of new biomarkers (measurable molecules in our body) in predicting the health outcome of patients with liver cirrhosis discharged from the hospital after a serious complication of the disease

Study Overview

Status

Recruiting

Conditions

Detailed Description

The PROSPECT study is part of the larger EU H2020 DECISION project, which aims to analyze and clarify the pathophysiological mechanisms of decompensated cirrhosis at the systemic level and its transition to ACLF, with the goal of significantly reducing mortality through therapies tailored to the specific needs of individual patients or patient groups.

As planned in the DECISION project, the biological samples of three large cohorts of patients with cirrhosis admitted to hospital for acute decompensation (AD) without ACLF, deriving from the EF-CLIF-promoted observational studies CANONIC and PREDICT (Europe) and ACLARA (South America) were analyzed to measure lipidomics, epigenomics, whole-blood transcriptomics, micro-RNA, serum metabolomics, plasma cytokines, and plasma extracellular vesicles.

Both system medicine approaches and more traditional methods of analysis have been applied to analyze and interpret the results. The analyses are still ongoing due to the very high number of variables and the complexity of associating -omics to clinical data, yet, some of these analyses have already generated solid data allowing the identification of novel biomarkers which can be further tested.

In the PROSPECT study, patients hospitalized for acute decompensation of liver cirrhosis, who meet the inclusion and exclusion criteria, will be enrolled after providing signed informed consent. Participants will be screened and included in the study within 48 hours prior to the expected discharge from the hospital. The study will last 180 days and will include an initial visit during which clinical parameters and additional blood samples will be collected, followed by two follow-up visits - which can also be conducted by phone - during which only clinical information will be gathered. Samples will be analyzed to determine the biomarkers selected within the DECISION project and parameters related to the following pathophysiological mechanisms:

  • systemic inflammation
  • blood and microRNA transcriptome
  • the metabolomic landscape
  • albumin structure and function
  • coagulation assays
  • extracellular vesicles
  • endothelial function

Study Type

Observational

Enrollment (Estimated)

189

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Clichy, France, 92110
        • Recruiting
        • Hospital Beaujon
        • Contact:
        • Principal Investigator:
          • Pierre-Emmanuel Rautou
  • Germany
      • Aachen, Germany, 52074
        • Recruiting
        • University Hospital, Aachen
        • Principal Investigator:
          • Tony Bruns
        • Contact:
      • Münster, Germany, 48149
        • Recruiting
        • Universitatsklinikum Munster
        • Principal Investigator:
          • Jonel Trebicka
        • Contact:
  • Italy
      • Torino, Italy, 10126
        • Recruiting
        • A.O.U. Città della Salute e Della Scienza di Torino
        • Principal Investigator:
          • Carlo Alessandria
        • Contact:
    • Italia
      • Bologna, Italia, Italy, 40138
        • Recruiting
        • IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di S.Orsola
        • Principal Investigator:
          • Paolo Caraceni
        • Contact:
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona
        • Contact:
        • Principal Investigator:
          • Javier Fernandez
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron Research Institute
        • Principal Investigator:
          • Joan Genescà
        • Contact:
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramon y Cajal
        • Contact:
        • Principal Investigator:
          • Agustín Albillos
  • United Kingdom
      • London, United Kingdom, NW3 2QG
        • Not yet recruiting
        • Royal Free Hospital
        • Contact:
        • Principal Investigator:
          • Raj Mookerjee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients eligible for this study will be patients with decompensated cirrhosis expected to be discharged from the hospital within 48 hours after an index admission for AD according to the EASL-CLIF criteria.

Description

Inclusion Criteria:

  1. Age between 18 and 80 years.
  2. Patients with decompensated cirrhosis admitted to hospital due to AD according to the EASL-CLIF criteria (rapid onset of ascites, hepatic encephalopathy, portal hypertensive- related gastrointestinal bleeding, bacterial infection, or any combination of these), including those who presented ACLF during hospitalization.
  3. Recovery from AD and expected to be discharged within the next 48 hours.

Exclusion Criteria:

  1. Admission for planned diagnostic or therapeutic procedures
  2. Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)
  3. Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.
  4. HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).
  5. Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician
  6. Previous liver or other organ transplantation
  7. Patients with TIPS or other surgical porto-caval shunts
  8. Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate <20 ml/min according to the MDRD equations
  9. Chronic heart failure NYHA class III or IV
  10. Pulmonary disease GOLD III or IV
  11. Patients with a history of significant extrahepatic disease with life expectancy <6 months
  12. Severe psychiatric disorders
  13. Pregnancy and breast-feeding
  14. Expected low adherence to study protocol as judged by physician
  15. Patients who cannot provide written informed consent or refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with Decompensated Liver Cirrhosis
Patients eligible for this study will be patients with decompensated cirrhosis expected to be discharged from the hospital within 48 hours after an index admission for AD according to the EASL-CLIF criteria

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To test the prognostic accuracy of novel biomarkers identified within the DECISION project.
Time Frame: Until September 30th 2025

The primary objective will be evaluated assessing the following end-point:

● Survival at 3 months
Until September 30th 2025

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To characterize the clinical and biological features at the time of discharge predicting the 6-month outcome and the different trajectories of patients surviving a hospitalization for AD complicated or not by ACLF.
Time Frame: Until September 30th 2025

Secondary objectives will be evaluated assessing the following end-points:

  • Survival at 6 months
  • Incidence of emergent re-admissions to hospital at 3 months due to liver related causes
  • Incidence of emergent re-admissions to hospital at 6 months due to liver related causes
  • Incidence of emergent re-admissions to hospital at 3 months due to non liver related causes
  • Incidence of emergent re-admissions to hospital at 6 months due to non liver related causes
  • Incidence of ACLF at 3 months
  • Incidence of ACLF at 6 months
  • Incidence of TIPS insertion at 3 months
  • Incidence of TIPS insertion at 6 months
Until September 30th 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Foundation for Study of Chronic Liver Failure

Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
Hospital Universitari Vall d'Hebron Research Institute
Beaujon Hospital
Hospital Universitario Ramon y Cajal
University Hospital, Aachen
Universität Münster
A.O.U. Città della Salute e della Scienza
Hospital Clinic de Barcelona, Barcelona, Spain

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 28, 2025

First Posted (Actual)

March 3, 2025

Study Record Updates

Last Update Posted (Actual)

August 6, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROSPECT
  • 847949 (Other Grant/Funding Number: European Health and Digital Executive Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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