We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02113865
First Posted: April 15, 2014
Last Update Posted: March 9, 2015
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.
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
  Purpose
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
Acquired Immunodeficiency Syndrome Virus Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted Hepatocellular Carcinoma

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • 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:
  • 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:
  • 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

Enrollment: 45
Study Start Date: October 2013
Study Completion Date: February 2015
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Grupo 0
Null or mild fibrosis
Grupo 1
Cirrhosis
Grupo 2
HCC diagnosis

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02113865


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

Responsible Party: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier: NCT02113865     History of Changes
Other Study ID Numbers: FMM115392013
First Submitted: April 7, 2014
First Posted: April 15, 2014
Last Update Posted: March 9, 2015
Last Verified: April 2014

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Immunologic Deficiency Syndromes
Acquired Immunodeficiency Syndrome
HIV Infections
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
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