Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2026-03-04 @ 7:31 AM
Study NCT ID:
NCT02785835
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2016-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hepatocellular Carcinoma in HIV-infected Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 477}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-15', 'studyFirstSubmitDate': '2016-05-25', 'studyFirstSubmitQcDate': '2016-05-25', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'At 1 year', 'description': 'Overall survival after HCC diagnosis at 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatocellular Carcinoma', 'HIV', 'Chronic Hepatitis C', 'Hepatitis B Virus', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '24056067', 'type': 'RESULT', 'citation': 'Merchante N, Merino E, Rodriguez-Arrondo F, Tural C, Munoz J, Delgado-Fernandez M, Jover F, Galindo MJ, Rivero A, Lopez-Aldeguer J, Aguirrebengoa K, Romero-Palacios A, Martinez E, Pineda JA. HIV/hepatitis C virus-coinfected patients who achieved sustained virological response are still at risk of developing hepatocellular carcinoma. AIDS. 2014 Jan 2;28(1):41-7. doi: 10.1097/QAD.0000000000000005.'}, {'pmid': '22955438', 'type': 'RESULT', 'citation': 'Merchante N, Merino E, Lopez-Aldeguer J, Jover F, Delgado-Fernandez M, Galindo MJ, Ortega E, Rivero A, Minguez C, Romero-Palacios A, Padilla S, Marquez-Solero M, Amador C, Rios-Villegas MJ, Tellez F, Portilla J, Pineda JA. Increasing incidence of hepatocellular carcinoma in HIV-infected patients in Spain. Clin Infect Dis. 2013 Jan;56(1):143-50. doi: 10.1093/cid/cis777. Epub 2012 Sep 5.'}, {'pmid': '27755109', 'type': 'RESULT', 'citation': 'Merchante N, Ibarra S, Revollo B, Rodriguez-Arrondo F, Merino E, Delgado-Fernandez M, Montero-Alonso M, Tellez F, Galindo MJ, Rivero-Juarez A, Garcia MA, Minguez C, Romero-Palacios A, Garcia-Deltoro M, Pineda JA; GEHEP-002 Study Group. Real-life experience with sorafenib for the treatment of hepatocellular carcinoma in HIV-infected patients. AIDS. 2017 Jan 2;31(1):89-95. doi: 10.1097/QAD.0000000000001293.'}, {'pmid': '29596108', 'type': 'RESULT', 'citation': 'Merchante N, Rodriguez-Arrondo F, Revollo B, Merino E, Ibarra S, Galindo MJ, Montero M, Garcia-Deltoro M, Rivero-Juarez A, Tellez F, Delgado-Fernandez M, Rios-Villegas MJ, Garcia MA, Vera-Mendez FJ, Ojeda-Burgos G, Lopez-Ruz MA, Metola L, Omar M, Aleman-Valls MR, Aguirrebengoa K, Portu J, Raffo M, Macias J, Pineda JA; GEHEP-002 Study Group. Hepatocellular carcinoma after sustained virological response with interferon-free regimens in HIV/hepatitis C virus-coinfected patients. AIDS. 2018 Jul 17;32(11):1423-1430. doi: 10.1097/QAD.0000000000001809.'}, {'pmid': '30562130', 'type': 'RESULT', 'citation': 'Pinato DJ, Allara E, Chen TY, Trevisani F, Minguez B, Zoli M, Harris M, Dalla Pria A, Merchante N, Platt H, Jain M, Caturelli E, Kikuchi L, Pineda J, Nelson M, Farinati F, Rapaccini GL, Aytaman A, Yin M, Tan CK, Bower M, Giannini EG, Brau N; Liver Cancer in HIV and ITA.LI.CA Study Groups. Influence of HIV Infection on the Natural History of Hepatocellular Carcinoma: Results From a Global Multicohort Study. J Clin Oncol. 2019 Feb 1;37(4):296-304. doi: 10.1200/JCO.18.00885. Epub 2018 Dec 18.'}, {'pmid': '30325782', 'type': 'RESULT', 'citation': 'Merchante N, Figueruela B, Rodriguez-Fernandez M, Rodriguez-Arrondo F, Revollo B, Ibarra S, Galindo MJ, Merino E, Montero M, Tellez F, Garcia-Deltoro M, Rivero-Juarez A, Delgado-Fernandez M, Rios-Villegas MJ, Aguirrebengoa K, Garcia MA, Portu J, Vera-Mendez FJ, Villalobos M, Minguez C, De Los Santos I, Lopez-Ruz MA, Omar M, Galera C, Macias J, Pineda JA; GEHEP-002 Study Group. Low performance of ultrasound surveillance for the diagnosis of hepatocellular carcinoma in HIV-infected patients. AIDS. 2019 Feb 1;33(2):269-278. doi: 10.1097/QAD.0000000000002065.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'HIV-infected patients who are diagnosed of hepatocellular carcinoma following AASLD criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HIV infection\n* Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02785835', 'acronym': 'GEHEP-002', 'briefTitle': 'Hepatocellular Carcinoma in HIV-infected Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario de Valme'}, 'officialTitle': 'Hepatocellular Carcinoma in HIV-infected Patients', 'orgStudyIdInfo': {'id': 'GEHEP-002'}, 'secondaryIdInfos': [{'id': 'RIS-VAC12', 'type': 'OTHER', 'domain': 'Instituto de Salud Carlos III'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Orihuela', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital de Orihuela', 'geoPoint': {'lat': 38.08483, 'lon': -0.94401}}, {'city': "Sant Joan d'Alacant", 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Clínico Universitario de San Juan', 'geoPoint': {'lat': 38.40148, 'lon': -0.43623}}, {'city': 'Villajoyosa', 'state': 'Alicante', 'country': 'Spain', 'facility': 'Hospital Marina Baixa', 'geoPoint': {'lat': 38.50754, 'lon': -0.23346}}, {'city': 'Badalona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital German Trias i Pujol', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Castellon', 'state': 'Castellón', 'country': 'Spain', 'facility': 'Hospital General de Castellón', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'city': 'La Línea de la Concepción', 'state': 'Cádiz', 'country': 'Spain', 'facility': 'Hospital de La Linea', 'geoPoint': {'lat': 36.16809, 'lon': -5.34777}}, {'city': 'San Sebastián', 'state': 'Guipúzcua', 'country': 'Spain', 'facility': 'Hospital Universitario de Donostia', 'geoPoint': {'lat': 43.56667, 'lon': -5.9}}, {'city': 'A Coruña', 'state': 'La Coruña', 'country': 'Spain', 'facility': 'Hospital Universitario A Coruña', 'geoPoint': {'lat': 43.37135, 'lon': -8.396}}, {'city': 'Logroño', 'state': 'La Rioja', 'country': 'Spain', 'facility': 'Hospital de San Pedro', 'geoPoint': {'lat': 42.46615, 'lon': -2.45115}}, {'city': 'Cartagena', 'state': 'Murcia', 'country': 'Spain', 'facility': 'Hospital de Santa Lucía', 'geoPoint': {'lat': 37.60197, 'lon': -0.98397}}, {'city': 'San Cristóbal de La Laguna', 'state': 'Santa Cruz De Tenerife', 'country': 'Spain', 'facility': 'Hospital Universitario de Canarias', 'geoPoint': {'lat': 28.4853, 'lon': -16.32014}}, {'city': 'Barakaldo', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de San Eloy', 'geoPoint': {'lat': 43.29639, 'lon': -2.98813}}, {'city': 'Basurto', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Basurto'}, {'city': 'Bilbao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Cruces', 'geoPoint': {'lat': 43.26271, 'lon': -2.92528}}, {'city': 'Galdakao', 'state': 'Vizcaya', 'country': 'Spain', 'facility': 'Hospital de Galdakao', 'geoPoint': {'lat': 43.23073, 'lon': -2.8429}}, {'city': 'Alicante', 'country': 'Spain', 'facility': 'Hospital General Universitario de Alicante', 'geoPoint': {'lat': 38.34517, 'lon': -0.48149}}, {'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital de Puerto Real', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Córdoba', 'country': 'Spain', 'facility': 'Hospital Universitario Reina Sofía', 'geoPoint': {'lat': 37.89155, 'lon': -4.77275}}, {'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'city': 'Huelva', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Huelva', 'geoPoint': {'lat': 37.26638, 'lon': -6.94004}}, {'city': 'Jaén', 'country': 'Spain', 'facility': 'Complejo Hospitalario de Jaén', 'geoPoint': {'lat': 37.76922, 'lon': -3.79028}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Regional Carlos Haya', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Málaga', 'country': 'Spain', 'facility': 'Hospital Virgen de la Victoria', 'geoPoint': {'lat': 36.72016, 'lon': -4.42034}}, {'city': 'Murcia', 'country': 'Spain', 'facility': 'Hospital Universitario Arrixaca', 'geoPoint': {'lat': 37.98704, 'lon': -1.13004}}, {'zip': '41011', 'city': 'Seville', 'country': 'Spain', 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Clínico de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital General de Valencia', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Valencia', 'country': 'Spain', 'facility': 'Hospital Universitario y Politécnico La Fe', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Vitoria-Gasteiz', 'state': 'Álava', 'country': 'Spain', 'facility': 'Hospital de Txagorritxu', 'geoPoint': {'lat': 42.84998, 'lon': -2.67268}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario de Valme', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Nicolás Merchante', 'investigatorAffiliation': 'Hospital Universitario de Valme'}}}}