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

Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02113865
• Other study ID #: FMM115392013
• Status: Completed
• Phase: N/A
• First received: April 7, 2014
• Last updated: March 6, 2015
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: April 2014
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Acquired Immunodeficiency Syndrome Virus
• Carcinoma, Hepatocellular
• Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
• Hepatocellular Carcinoma
• HIV Infections
• Immunologic Deficiency Syndromes

Locations

Country	Name	City	State
Spain	Hospital Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of genetic polymorphisms distribution between study groups of relevant genes probably implicated in the disease	Genetic polymorphisms will be evaluated using Real-Time polymerase chain reaction technique	1 day (Routine visit in normal following at Infectious Disease Department)	No
Primary	Sera inflammatory markers	Inflammatory markers will be measure used a Enzyme-linked Immunosorbent Assay	1 day (Routine visit to normal following in Infectious Disease Department)	No
Secondary	Sera apoptotic markers	Apoptotic markers will be evaluated through a Enzyme-linked Immunosorbent Assay	1 day (Routine visit in disease following at Infectious Disease Department)	No