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

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT02113865

FMM115392013

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

45 participants in 3 patient groups

Grupo 0

Description:

Null or mild fibrosis

Grupo 1

Description:

Cirrhosis

Grupo 2

Description:

HCC diagnosis