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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02113865
Other study ID # FMM115392013
Secondary ID
Status Completed
Phase N/A
First received April 7, 2014
Last updated March 6, 2015
Start date October 2013
Est. completion date February 2015

Study information

Verified date April 2014
Source Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contact n/a
Is FDA regulated No
Health authority Spain: Comité Ético de Investigación Clínica
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date February 2015
Est. primary completion date October 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Spain Hospital Ramón y Cajal Madrid

Sponsors (2)

Lead Sponsor Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal Fundación Mutua Madrileña

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Evaluation of genetic polymorphisms distribution between study groups of relevant genes probably implicated in the disease Genetic polymorphisms will be evaluated using Real-Time polymerase chain reaction technique 1 day (Routine visit in normal following at Infectious Disease Department) No
Primary Sera inflammatory markers Inflammatory markers will be measure used a Enzyme-linked Immunosorbent Assay 1 day (Routine visit to normal following in Infectious Disease Department) No
Secondary Sera apoptotic markers Apoptotic markers will be evaluated through a Enzyme-linked Immunosorbent Assay 1 day (Routine visit in disease following at Infectious Disease Department) No
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