Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-02 @ 12:10 AM
Study NCT ID:
NCT06855056
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis
Sponsor:
European Foundation for Study of Chronic Liver Failure
Organization:
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROSPECT
Brief 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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 847949 | OTHER_GRANT | European Health and Digital Executive Agency | View |