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

Evaluation of the Role of Plasma Biomarkers for Portal Hypertension Progression and Oxidative Damage in Decompensation of Cirrhotic Patient.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03084185

Enrollment

200

Registered

2017-03-20

Start date

2012-12-31

Completion date

2018-12-31

Last updated

2017-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis

Keywords

decompensation, deficit, metabolomics, portal hypertension

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Diagnosis of liver cirrhosis * Aged between 18 and 75 years * Obtaining written informed consent * Absence of

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

Italy

Contacts

Primary ContactERICA VILLA, MD

erica.villa@unimore.it+39 0594225308

Outcome results