- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02113865
Score System for Prediction Risk and Early Diagnosis of HCC in HIV/HCV Patients
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 Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Madrid, Spain
- Hospital Ramon y Cajal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Grupo 0
Null or mild fibrosis
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Grupo 1
Cirrhosis
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Grupo 2
HCC diagnosis
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sera inflammatory markers
Time Frame: 1 day (Routine visit to normal following in Infectious Disease Department)
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Inflammatory markers will be measure used a Enzyme-linked Immunosorbent Assay
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1 day (Routine visit to normal following in Infectious Disease Department)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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1 day (Routine visit in disease following at Infectious Disease Department)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
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Genetic polymorphisms will be evaluated using Real-Time polymerase chain reaction technique
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1 day (Routine visit in normal following at Infectious Disease Department)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Beatriz S Sastre, PhD, Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Sexually Transmitted Diseases, Viral
- Sexually Transmitted Diseases
- Lentivirus Infections
- Retroviridae Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Slow Virus Diseases
- HIV Infections
- Carcinoma
- Acquired Immunodeficiency Syndrome
- Immunologic Deficiency Syndromes
Other Study ID Numbers
- FMM115392013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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