NCT06855056

Validation of New Prognostic Biomarkers in Patients With 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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 189 (estimated)
• Sponsor: European Foundation for Study of Chronic Liver Failure · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

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

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-03-30
• Completion: 2026-09-30
• First posted: 2025-03-03
• Last updated: 2025-08-06

Locations

9 sites across 5 countries: France, Germany, Italy, Spain, United Kingdom