Liver CirrhosisPROSPECTNCT06855056
Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis
An observational study of Liver Cirrhosis and Decompensated Cirrhosis of Liver, run by European Foundation for Study of Chronic Liver Failure at 9 sites in 5 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Decompensated Cirrhosis of Liver
- How many people
- 189 participants
- Where
- 9 sitesin 5 countries
- Study dates
- 1 Mar 2025to 1 Sep 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age between 18 and 80 years.
- 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.
- Recovery from AD and expected to be discharged within the next 48 hours.
Who cannot join
- Admission for planned diagnostic or therapeutic procedures
- Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)
- Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.
- HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).
- Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician
- Previous liver or other organ transplantation
Show all 15Show fewer
- Patients with TIPS or other surgical porto-caval shunts
- Chronic organic renal failure stage IV and V or estimated Glomerular Filtration Rate <20 ml/min according to the MDRD equations
- Chronic heart failure NYHA class III or IV
- Pulmonary disease GOLD III or IV
- Patients with a history of significant extrahepatic disease with life expectancy <6 months
- Severe psychiatric disorders
- Pregnancy and breast-feeding
- Expected low adherence to study protocol as judged by physician
- Patients who cannot provide written informed consent or refuse to participate
Trial locations and contacts
9 sites in 5 countries.
9 sites in 5 countries
Spain3 sites
Hospital Universitari Vall d'Hebron Research Institute
Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, 08036
Hospital Universitario Ramon y Cajal
Madrid, 28034
Germany2 sites
University Hospital, Aachen
Aachen, 52074
Universitätsklinikum Münster
Münster, 48149
Italy2 sites
IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di S.Orsola
Bologna, Italia, 40138
A.O.U. Città della Salute e della Scienza di Torino
Torino, 10126
About this study
Official title: 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
Read the 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
- Conditions
- Liver Cirrhosis, Decompensated Cirrhosis of Liver
- Keywords
- Decompensated Liver Cirrhosis, Acute on Chronic Liver Failure (ACLF), Liver Diseases, Liver Cirrhosis, Biomarkers
- Medical subject headings
- Liver Cirrhosis, Acute-On-Chronic Liver Failure, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
To test the prognostic accuracy of novel biomarkers identified within the DECISION project.
The primary objective will be evaluated assessing the following end-point:
● Survival at 3 months
Measured: Until September 30th 2025
Secondary outcomes (1)
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.
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
Measured: Until September 30th 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start1 Mar 2025
- Primary completion1 Jul 2026
- Study completion1 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 189 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Foundation for Study of Chronic Liver Failure
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Münster, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Hospital Universitari Vall d'Hebron Research Institute, Hospital Clinic of Barcelona, Hospital Universitario Ramon y Cajal, Beaujon Hospital, University Hospital, Aachen, A.O.U. Città della Salute e della Scienza
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855056
- Sponsor's protocol ID
- PROSPECT
- Other IDs
- 847949
- Acronym
- PROSPECT
- Status last verified
- Sep 2026
- First submitted
- 10 Feb 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of New Prognostic biomarkerRs in Patients With cirrhOsis diScharged After a hosPitalization Due to acutE deCompensation or acuTe-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT06855056
- Acronym / sponsor ID
- PROSPECT / PROSPECT
- Conditions
- Liver Cirrhosis, Decompensated Cirrhosis of Liver
- Keywords
- Decompensated Liver Cirrhosis, Acute on Chronic Liver Failure (ACLF), Liver Diseases, Liver Cirrhosis, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 189 participants (actual)
- Lead sponsor
- European Foundation for Study of Chronic Liver FailureUniversity, hospital or other
- Collaborators
- Universität Münster, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Hospital Universitari Vall d'Hebron Research Institute, Hospital Clinic of Barcelona, Hospital Universitario Ramon y Cajal, Beaujon Hospital, University Hospital, Aachen, A.O.U. Città della Salute e della Scienza
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Sep 2026 (actual)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age between 18 and 80 years.
- 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.
- Recovery from AD and expected to be discharged within the next 48 hours.
Key exclusion criteria (15 listed)
- Admission for planned diagnostic or therapeutic procedures
- Active malignancy (except for hepatocellular carcinoma within the Milan criteria or nonmelanocytic skin cancer)
- Antiviral treatment for hepatitis C, B and delta initiated in the last 6 months or planned to be initiated in the following 6 months.
- HIV positive (except undergoing treatment and who do not exhibit clinical manifestations of AIDS).
- Ongoing alcohol use disorder with an expected low adherence to prescriptions as judged by physician
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cirrhosis and Decompensated Cirrhosis of Liver, run by European Foundation for Study of Chronic Liver Failure at 9 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain, Germany, Italy, France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To test the prognostic accuracy of novel biomarkers identified within the DECISION project. (time frame: Until September 30th 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.