New biomarkers to predict outcomes after hospitalization for decompensated cirrhosis
Validation of New Prognostic biomarkerRs in Patients With cirrhOsis diScharged After a hosPitalization Due to acutE deCompensation or acuTe-on-chronic Liver Failure
This will test whether new blood and molecular markers can help predict which adults with decompensated liver cirrhosis will do well or have complications after they leave the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 189 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | European Foundation for Study of Chronic Liver Failure Academic / other |
| Locations | 9 sites (Clichy, France and 8 other locations) |
| Trial ID | NCT06855056 on ClinicalTrials.gov |
What this trial studies
PROSPECT enrolls adults hospitalized for acute decompensation of cirrhosis who have recovered and are expected to be discharged within 48 hours, collecting biological samples for biomarker testing. The work builds on multi-cohort -omics analyses (lipidomics, epigenomics, transcriptomics, micro-RNA, metabolomics, cytokines, extracellular vesicles) done in CANONIC, PREDICT, and ACLARA under the EU DECISION program. Both systems-medicine and conventional analytic methods are being used to link molecular signatures to clinical outcomes. The current study aims to validate candidate prognostic biomarkers already identified in those large observational cohorts across participating European centers.
Who should consider this trial
Good fit: Adults aged 18–80 who were hospitalized for acute decompensation of liver cirrhosis (with or without ACLF during admission), have recovered from the acute event, and are expected to be discharged within 48 hours are the intended participants.
Not a fit: Patients with active nonallowed cancers, very recent or planned antiviral starts, uncontrolled alcohol use, certain untreated HIV/AIDS, planned admissions for procedures, or those not treated at participating hospitals are unlikely to be eligible or benefit from this validation effort.
Why it matters
Potential benefit: If successful, these biomarkers could help doctors identify patients at higher risk after discharge so they can receive closer follow-up or tailored treatments to reduce complications and death.
How similar studies have performed: Previous multi-omics analyses within the DECISION program and large cohorts have produced promising candidate biomarkers, but these require prospective validation as planned here.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clichy, France and 8 other locations
- Hospital Beaujon — Clichy, France, France (Recruiting)
- University Hospital, Aachen — Aachen, Germany, Germany (Recruiting)
- Universitätsklinikum Münster — Münster, Germany, Germany (Recruiting)
- IRCCS Azienda Ospedaliero Universitaria di Bologna Policlinico di S.Orsola — Bologna, Italia, Italy (Recruiting)
- A.O.U. Città della Salute e della Scienza di Torino — Torino, Italy, Italy (Recruiting)
- Hospital Universitari Vall d'Hebron Research Institute — Barcelona, Spain, Spain (Recruiting)
- Hospital Clinic de Barcelona — Barcelona, Spain, Spain (Recruiting)
- Hospital Universitario Ramon y Cajal — Madrid, Spain, Spain (Recruiting)
- Royal Free Hospital — London, United Kingdom, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Anna Bosch
- Email: anna.bosch@efclif.com
- Phone: +34 93 227 14 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.