Hepatocellular CarcinomaGEHEP-002NCT02785835
Hepatocellular Carcinoma in HIV-infected Patients
An observational study of Hepatocellular Carcinoma and HIV, run by Hospital Universitario de Valme at 30 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, HIV, Chronic Hepatitis C
- How many people
- 477 participants
- Where
- 30 sitesSpain
- Study dates
- May 2014to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: HIV-infected patients who are diagnosed of hepatocellular carcinoma following AASLD criteria.
Who may be able to join
- HIV infection
- Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria
Who cannot join
- None
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Spain30 sites
Hospital Universitario A Coruña
A Coruña, La Coruña
Hospital General Universitario de Alicante
Alicante
Hospital German Trias i Pujol
Badalona, Barcelona
Hospital de San Eloy
Barakaldo, Vizcaya
Hospital de Basurto
Basurto, Vizcaya
Hospital de Cruces
Bilbao, Vizcaya
Hospital de Puerto Real
Cadiz
Hospital de Santa Lucía
Cartagena, Murcia
Hospital General de Castellón
Castellon, Castellón
Hospital Universitario Reina Sofía
Córdoba
Hospital de Galdakao
Galdakao, Vizcaya
Hospital Universitario Virgen de las Nieves
Granada
Complejo Hospitalario de Huelva
Huelva
Complejo Hospitalario de Jaén
Jaén
Hospital de La Linea
La Línea de la Concepción, Cádiz
Hospital de San Pedro
Logroño, La Rioja
Hospital Universitario La Princesa
Madrid
Hospital Regional Carlos Haya
Málaga
Hospital Virgen de la Victoria
Málaga
Hospital Universitario Arrixaca
Murcia
Hospital de Orihuela
Orihuela, Alicante
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Santa Cruz De Tenerife
Hospital Universitario de Donostia
San Sebastián, Guipúzcua
Hospital Clínico Universitario de San Juan
Sant Joan d'Alacant, Alicante
Hospital Universitario Virgen Macarena
Seville, 41011
Hospital Clínico de Valencia
Valencia
Hospital General de Valencia
Valencia
Hospital Universitario y Politécnico La Fe
Valencia
Hospital Marina Baixa
Villajoyosa, Alicante
Hospital de Txagorritxu
Vitoria-Gasteiz, Álava
About this study
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.
- Medical subject headings
- Carcinoma, Hepatocellular, Hepatitis C, Chronic, Hepatitis B, Liver Cirrhosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Overall survival after HCC diagnosis at 1 year
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startMay 2014
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 477 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Valme
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolás Merchante, Hospital Universitario de Valme
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785835
- Sponsor's protocol ID
- GEHEP-002
- Other IDs
- RIS-VAC12
- Acronym
- GEHEP-002
- Status last verified
- Mar 2022
- First submitted
- 25 May 2016
- Last updated
- 16 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24056067Merchante 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.
PubMed 22955438Merchante 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.
PubMed 27755109Merchante 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.
PubMed 29596108Pinato 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.
PubMed 30562130Merchante 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.
PubMed 30325782
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatocellular Carcinoma in HIV-infected Patients
- ClinicalTrials.gov ID
- NCT02785835
- Acronym / sponsor ID
- GEHEP-002 / GEHEP-002
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 477 participants (actual)
- Lead sponsor
- Hospital Universitario de ValmeUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 30 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- HIV-infected patients who are diagnosed of hepatocellular carcinoma following AASLD criteria.
Key inclusion criteria (2 listed)
- HIV infection
- Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival
Time frame: At 1 year
Overall survival after HCC diagnosis at 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2022.
- Results publication: PubMed 24056067Merchante 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.
- Results publication: PubMed 22955438Merchante 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.
- Results publication: PubMed 27755109Merchante 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.
- Results publication: PubMed 29596108Merchante 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.
- Results publication: PubMed 30562130Pinato 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.
- Results publication: PubMed 30325782Merchante 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and HIV, run by Hospital Universitario de Valme at 30 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: At 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02785835, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2022.