Evaluation of the Role of Plasma Biomarkers in the Development of Decompensation in Patients With Cirrhosis .

• Conditions: Cirrhosis

• Registration Number: NCT03084185
• Lead Sponsor: University of Modena and Reggio Emilia

Brief Summary

This is a single-center and prospective study to identify specific biomarker in order to predict development of decompensation in cirrhotic patients.

The duration of the study is 36 months and it provides a cohort of 200 patients.

Detailed Description

At screening, patient will have taken blood samples and performed hepatic vein pressure gradient.

After randomization, patient will be seen at follow up every 3 months to do blood sample and every 12 months to undergo hepatic vein pressure gradient , according to the guidelines.

In addition, metabolomics analysis will be performed at screening and every 3 months. The results will be analyzed in relation to emergence of decompensation during follow up period, in order to identify specific metabolomics characteristics that may be able to predict decompensation.

Study Timeline

• Study Start: 2012-12
• Status Verified: 2017-03
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-13
• Study First Posted: 2017-03-20
• Last Update Submitted: 2017-09-12
• Last Update Posted: 2017-09-13
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Diagnosis of liver cirrhosis
• Aged between 18 and 75 years
• Obtaining written informed consent
• Absence of exclusion criteria

Exclusion Criteria

• Diagnosis of hepatocellular carcinoma
• Presence of portal vein thrombosis
• HIV
• Liver transplantation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis.	December 2018	Patients will be subject to blood sample periodically and following exams will be made: * Chemistry and hematology to define liver function; * Intestinal Fatty Acid Binding Protein; * 16S, ribosomal deoxyribonucleic acid; * Cluster of differentiation 14; * Interleukin 6; * Asymmetrical dimethylarginine; * Tissue factor; According to current guidelines, patients will be submitted to: * Hepatic vein pressure gradient AND combined right heart catheterization; * Liver elastography

Secondary Outcome Measures

Name	Time	Method
Finding of serum metabolomic features of cirrhotic patients.	December 2018	Analysis will be conducted on sera collected during the screening and every three months. These samples will be examined using liquid chromatography and mass spectrometry in order to obtain the identification of main components and their mass than, the informations will be analyzed by MarkerLynxTM software

Trial Locations

Locations (1)

Azienda Ospedaliera Universitaria Policlinico Di Modena; 🇮🇹 Modena, MO, Italy