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OpenTrials
Completed

NCT Number: NCT02113865

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

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).

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Key information

Conditions

Acquired Immunodeficiency Syndrome Virus Acquired Immunodeficiency Syndrome Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases Digestive System Diseases Digestive System Neoplasms Flaviviridae Infections Genital Diseases HIV Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted Hepatocellular Carcinoma Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Ramón y Cajal

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Sera inflammatory markers

    Time frame: 1 day (Routine visit to normal following in Infectious Disease Department)

    Inflammatory markers will be measure used a Enzyme-linked Immunosorbent Assay

Secondary outcomes

  1. Sera apoptotic markers

    Time frame: 1 day (Routine visit in disease following at Infectious Disease Department)

    Apoptotic markers will be evaluated through a Enzyme-linked Immunosorbent Assay

Other outcomes

  1. Evaluation of genetic polymorphisms distribution between study groups of relevant genes probably implicated in the disease

    Time frame: 1 day (Routine visit in normal following at Infectious Disease Department)

    Genetic polymorphisms will be evaluated using Real-Time polymerase chain reaction technique

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Collaborators

  • Fundación Mutua Madrileña

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Apr 15, 2014
Registry last updated
Mar 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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