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

Completed

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

• Registration Number: NCT02113865
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Study Timeline

• Study Start: 2013-10
• Status Verified: 2014-04
• Study First Submitted: 2014-04-07
• Study First Submitted QC: 2014-04-14
• Study First Posted: 2014-04-15
• Primary Completion: 2014-10
• Study Completion: 2015-02
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hospital Ramón y Cajal; 🇪🇸 Madrid, Spain