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

Obtención de un Panel de puntuación (Score System) Para la predicción de Riesgo Individualizado y la detección Precoz de Carcinoma Hepatocelular (HCC) en Sujetos Coinfectados VIH/VHC

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02113865

Enrollment

Registered

2014-04-15

Start date

2013-10-31

Completion date

2015-02-28

Last updated

2015-03-09

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

Conditions

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

Brief summary

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

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.

Interventions

None listed

Study design

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Sera inflammatory markers	1 day (Routine visit to normal following in Infectious Disease Department)	Inflammatory markers will be measure used a Enzyme-linked Immunosorbent Assay

Secondary

Measure	Time frame	Description
Sera apoptotic markers	1 day (Routine visit in disease following at Infectious Disease Department)	Apoptotic markers will be evaluated through a Enzyme-linked Immunosorbent Assay

Other

Measure	Time frame	Description
Evaluation of genetic polymorphisms distribution between study groups of relevant genes probably implicated in the disease	1 day (Routine visit in normal following at Infectious Disease Department)	Genetic polymorphisms will be evaluated using Real-Time polymerase chain reaction technique

Countries

Spain

Outcome results