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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02113865
Recruitment Status : Completed
First Posted : April 15, 2014
Last Update Posted : March 9, 2015
Fundación Mutua Madrileña
Information provided by (Responsible Party):
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).

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

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 Type : Observational
Actual Enrollment : 45 participants
Time Perspective: Cross-Sectional
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
Study Start Date : October 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Grupo 0
Null or mild fibrosis
Grupo 1
Grupo 2
HCC diagnosis

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Biospecimen Retention:   Samples With DNA
Serum, plasma, white cells

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HIV/HCV coinfected patients from Infectious Diseases Department

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02113865

Hospital Ramón y Cajal
Madrid, Spain
Sponsors and Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Fundación Mutua Madrileña
Principal Investigator: Beatriz S Sastre, PhD Fundación para la Investigación Biomédica del Hospital Ramón y Cajal

Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Identifier: NCT02113865     History of Changes
Other Study ID Numbers: FMM115392013
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: March 9, 2015
Last Verified: April 2014

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases