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

September 12, 2017 updated by: ERICA VILLA, University of Modena and Reggio Emilia

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MO
      • Modena, MO, Italy, 41124
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Di Modena
        • Contact:
        • Contact:
        • Principal Investigator:
          • ERICA VILLA, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with cirrhosis

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of predictive biomarkers for the deficit development in patients with compensated cirrhosis.
Time Frame: 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
December 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Finding of serum metabolomic features of cirrhotic patients.
Time Frame: 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
December 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Modena and Reggio Emilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 13, 2017

First Posted (Actual)

March 20, 2017

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HVPG_HCV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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