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GEHEP-002: Hepatocellular Carcinoma in HIV-infected Patients

Sponsor
Hospital Universitario de Valme (Other)
Overall Status
Completed
CT.gov ID
NCT02785835
Collaborator
(none)
477
Enrollment
30
Locations
86
Duration (Months)
15.9
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Observational study. All HIV-infected patients who have been diagnosed of hepatocellular carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD) criteria, in the participant centers are included. Epidemiological, clinical and laboratory data are collected. The clinical and epidemiological characteristics of HCC cases will be analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed. Mortality and its predictors will be also assessed. In those cases infected by hepatitis C virus (HCV), the impact of HCV therapy on outcomes will be analysed.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    477 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Hepatocellular Carcinoma in HIV-infected Patients
    Study Start Date :
    May 1, 2014
    Actual Primary Completion Date :
    Jun 30, 2021
    Actual Study Completion Date :
    Jun 30, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [At 1 year]

      Overall survival after HCC diagnosis at 1 year

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • HIV infection

    • Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital de Orihuela Orihuela Alicante Spain
    2 Hospital Clínico Universitario de San Juan San Juan de Alicante Alicante Spain
    3 Hospital Marina Baixa Villajoyosa Alicante Spain
    4 Hospital German Trias i Pujol Badalona Barcelona Spain
    5 Hospital General de Castellón Castellón De La Plana Castellón Spain
    6 Hospital de La Linea La Línea de la Concepción Cádiz Spain
    7 Hospital Universitario de Donostia San Sebastián Guipúzcua Spain
    8 Hospital Universitario A Coruña A Coruna La Coruña Spain
    9 Hospital de San Pedro Logroño La Rioja Spain
    10 Hospital de Santa Lucía Cartagena Murcia Spain
    11 Hospital Universitario de Canarias San Cristóbal de la Laguna Santa Cruz De Tenerife Spain
    12 Hospital de San Eloy Barakaldo Vizcaya Spain
    13 Hospital de Basurto Basurto Vizcaya Spain
    14 Hospital de Cruces Bilbao Vizcaya Spain
    15 Hospital de Galdakao Galdakao Vizcaya Spain
    16 Hospital General Universitario de Alicante Alicante Spain
    17 Hospital de Puerto Real Cádiz Spain
    18 Hospital Universitario Reina Sofía Córdoba Spain
    19 Hospital Universitario Virgen de las Nieves Granada Spain
    20 Complejo Hospitalario de Huelva Huelva Spain
    21 Complejo Hospitalario de Jaén Jaén Spain
    22 Hospital Universitario La Princesa Madrid Spain
    23 Hospital Universitario Arrixaca Murcia Spain
    24 Hospital Regional Carlos Haya Málaga Spain
    25 Hospital Virgen de la Victoria Málaga Spain
    26 Hospital Universitario Virgen Macarena Sevilla Spain 41011
    27 Hospital Clínico de Valencia Valencia Spain
    28 Hospital General de Valencia Valencia Spain
    29 Hospital Universitario y Politécnico La Fe Valencia Spain
    30 Hospital de Txagorritxu Vitoria Álava Spain

    Sponsors and Collaborators

    • Hospital Universitario de Valme

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nicolás Merchante, MD, PhD, Hospital Universitario de Valme
    ClinicalTrials.gov Identifier:
    NCT02785835
    Other Study ID Numbers:
    • GEHEP-002
    • RIS-VAC12
    First Posted:
    May 30, 2016
    Last Update Posted:
    Mar 16, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    Hepatitis B
    Hepatitis C, Chronic
    Carcinoma
    Carcinoma, Hepatocellular
    Hepatitis
    Liver Cirrhosis

    Study Results

    No Results Posted as of Mar 16, 2022