Score System for Prediction Risk and Early Diagnosis of HCC in HIV/HCV Patients

NCT ID: NCT02113865

Last Updated: 2015-03-09

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

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-02-28

Brief Summary

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The aim of this study is to establish a clinical score panel based on clinical, molecular and genetic parameters that allow us to stratify and obtain an early detection of patients with an increased risk of developing hepatocellular carcinoma (HCC).

Detailed Description

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Transversal study design like a "proof of concept".

Primary objective:

The main objective is try to stablish a descriptive panel (first phase of a score system) based in the conjunction or sum of several clinical and laboratory parameters (molecular and genetic factors). The aim is to detect in a fast, early and successful way those patients that presents a high risk to develop an hepatocellular carcinoma (HCC) in the future in a specific population: HIV and HCV coinfected patients. The establishment of this panel will allow clinicians set up a correct treatment decreasing the probability of liver cirrhosis and HCC.

Conditions

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Acquired Immunodeficiency Syndrome Virus Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted Hepatocellular Carcinoma

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Grupo 0

Null or mild fibrosis

No interventions assigned to this group

Grupo 1

Cirrhosis

No interventions assigned to this group

Grupo 2

HCC diagnosis

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Human immunodeficiency virus chronic infection
* Hepatitis C virus chronic infection
* No other liver viral coinfections

Exclusion Criteria

* Alcohol consume
* Immunosuppressor or immunoactive treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Mutua Madrileña

OTHER

Sponsor Role collaborator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beatriz S Sastre, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundación para la Investigación Biomédica del Hospital Ramón y Cajal

Locations

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Hospital Ramón y Cajal

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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FMM115392013

Identifier Type: -

Identifier Source: org_study_id

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