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

NCT02113865 | Completed

• 1 other identifier: FMM115392013
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acquired Immunodeficiency Syndrome Virus; Hepatitis, Viral, Non-A, Non-B, Parenterally-Transmitted; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Sera apoptotic markers

  1 day (Routine visit in disease following at Infectious Disease Department)

Other Outcomes (1)

• Evaluation of genetic polymorphisms distribution between study groups of relevant genes probably implicated in the disease

  1 day (Routine visit in normal following at Infectious Disease Department)

Study Arms (3)

Grupo 0

Null or mild fibrosis

Grupo 1

Cirrhosis

Grupo 2

HCC diagnosis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV/HCV coinfected patients from Infectious Diseases Department

You may qualify if:

• Human immunodeficiency virus chronic infection
• Hepatitis C virus chronic infection
• No other liver viral coinfections

You may not qualify if:

• Alcohol consume
• Immunosuppressor or immunoactive treatment

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Fundación Mutua Madrileña: collaborator

Study Sites (1)

Hospital Ramón y Cajal

Madrid, Spain

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, white cells

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis C; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Study Officials

• Beatriz S Sastre, PhD

  Fundación para la Investigación Biomédica del Hospital Ramón y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2014
• First Posted: April 15, 2014
• Study Start: October 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: February 1, 2015
• Last Updated: March 9, 2015

Record last verified: 2014-04

Locations

ES (1)