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Hepatocellular Carcinoma in HIV-infected Patients (GEHEP-002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02785835
Recruitment Status : Recruiting
First Posted : May 30, 2016
Last Update Posted : February 17, 2020
Information provided by (Responsible Party):
Nicolás Merchante, Hospital Universitario de Valme

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
Hepatocellular Carcinoma HIV Chronic Hepatitis C Hepatitis B Virus Liver Cirrhosis

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Study Type : Observational
Estimated Enrollment : 302 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Hepatocellular Carcinoma in HIV-infected Patients
Study Start Date : May 2014
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2020

Primary Outcome Measures :
  1. Overall survival [ Time Frame: At 1 year ]
    Overall survival after HCC diagnosis at 1 year

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
HIV-infected patients who are diagnosed of hepatocellular carcinoma following AASLD criteria.

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02785835

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Contact: Nicolás Merchante, MD, PhD 955015684

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Sponsors and Collaborators
Hospital Universitario de Valme
Publications of Results:

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Responsible Party: Nicolás Merchante, MD, PhD, Hospital Universitario de Valme Identifier: NCT02785835    
Other Study ID Numbers: GEHEP-002
RIS-VAC12 ( Other Identifier: Instituto de Salud Carlos III )
First Posted: May 30, 2016    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis C, Chronic
Carcinoma, Hepatocellular
Liver Cirrhosis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic