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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fundación Mutua Madrileña
Information provided by (Responsible Party):
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT02113865
First received: April 7, 2014
Last updated: October 23, 2014
Last verified: April 2014
  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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Genetic polymorphisms will be evaluated using Real-Time polymerase chain reaction technique


Biospecimen Retention:   Samples With DNA

Serum, plasma, white cells


Estimated Enrollment: 30
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 7, 2014
Last Updated: October 23, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on October 23, 2014