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).
Acquired Immunodeficiency Syndrome Virus
Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted
|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|
- 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
- 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
- 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
|Study Start Date:||October 2013|
|Estimated Study Completion Date:||December 2014|
|Primary Completion Date:||October 2014 (Final data collection date for primary outcome measure)|
Null or mild fibrosis
Transversal study design like a "proof of concept".
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02113865
|Hospital Ramón y Cajal|
|Principal Investigator:||Beatriz S Sastre, PhD||Fundación para la Investigación Biomédica del Hospital Ramón y Cajal|