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

NCT ID: NCT03084185

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Diagnosis of hepatocellular carcinoma
* Presence of portal vein thrombosis
* HIV
* Liver transplantation
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Modena and Reggio Emilia

OTHER

Sponsor Role lead

Responsible Party

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ERICA VILLA

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ERICA VILLA, MD

Role: PRINCIPAL_INVESTIGATOR

University of Modena and Reggio Emilia

Locations

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Azienda Ospedaliera Universitaria Policlinico Di Modena

Modena, MO, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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ERICA VILLA, MD

Role: CONTACT

+39 0594225308

Facility Contacts

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ERICA VILLA, MD

Role: primary

0594225308

Role: backup

Other Identifiers

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HVPG_HCV

Identifier Type: -

Identifier Source: org_study_id

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