Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection

Abstract Background The incidence of non-AIDS defining cancer (NADC) is higher in people living with HIV (PLWH) than in the general population, and it is already one of the leading causes of death in the HIV-infected population. It is estimated that the situation will be aggravated by the progressiv...

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Autores principales:	M. Masiá, S. Padilla, G. Estañ, J. Portu, A. Silva, A. Rivero, A. González-Cordón, L. García-Fraile, O. Martínez, E. Bernal, C. Galera, V. Boix Martínez, J. Macias, M. Montero, D. García-Rosado, M. J. Vivancos-Gallego, J. Llenas-García, M. Torralba, J. A. García, V. Agulló, M. González-Fernández, F. Gutiérrez, E. Martínez, IMPAC-NEO Study Group
Formato:	article
Lenguaje:	EN
Publicado:	BMC 2021
Materias:	HIV infection Neoplasms Cancer Non-AIDS-defining cancers Screening Early detection of cancer Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/18d46939dfdc4e3592c6a450f8dfd747
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spelling	oai:doaj.org-article:18d46939dfdc4e3592c6a450f8dfd7472021-11-28T12:28:40ZImpact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection10.1186/s13063-021-05777-61745-6215https://doaj.org/article/18d46939dfdc4e3592c6a450f8dfd7472021-11-01T00:00:00Zhttps://doi.org/10.1186/s13063-021-05777-6https://doaj.org/toc/1745-6215Abstract Background The incidence of non-AIDS defining cancer (NADC) is higher in people living with HIV (PLWH) than in the general population, and it is already one of the leading causes of death in the HIV-infected population. It is estimated that the situation will be aggravated by the progressive aging of PLWH. Early diagnosis through intensive cancer screening may improve the ability for therapeutic interventions and could be critical in reducing mortality, but it might also increase expenditure and harms associated with adverse events. The aim of this study is to evaluate an enhanced screening program for early diagnosis of cancer in PLWH compared to standard practice. The specific objectives are (1) to compare the frequency of cancer diagnosed at an early stage, (2) to analyze safety of the enhanced program: adverse events and unnecessary interventions, (3) to analyze the cost-utility of the program, and (4) to estimate the overall and site-specific incidence of NADC in PLWH. Methods We will conduct a multicenter, non-blinded, randomized, controlled trial, comparing two parallel arms: conventional vs enhanced screening. Data will be recorded in an electronic data collection notebook. Conventional intervention group will follow the standard of care screening in the participating centers, according to the European AIDS Clinical Society recommendations, and the enhanced intervention group will follow an expanded screening aimed to early detection of lung, liver, anal, cervical, breast, prostate, colorectal, and skin cancer. The trial will be conducted within the framework of the Spanish AIDS Research Network Cohort (CoRIS). Discussion The trial will evaluate the efficacy, safety, and efficiency of an enhanced screening program for the early diagnosis of cancer in HIV patients compared to standard of care practice. The information provided will be relevant since there are currently no studies on expanded cancer screening strategies in patients with HIV, and available data estimating cost effectiveness or cost-utility of such as programs are scarce. An enhanced program for NADC screening in patients with HIV could lead to early diagnosis and improve the prognosis of these patients, with an acceptable rate of unnecessary interventions, but it is critical to demonstrate that the benefits clearly outweigh the harms, before the strategy could be implemented. Trial registration ClinicalTrials.gov NCT04735445. Registered on 25 June 2019M. MasiáS. PadillaG. EstañJ. PortuA. SilvaA. RiveroA. González-CordónL. García-FraileO. MartínezE. BernalC. GaleraV. Boix MartínezJ. MaciasM. MonteroD. García-RosadoM. J. Vivancos-GallegoJ. Llenas-GarcíaM. TorralbaJ. A. GarcíaV. AgullóM. González-FernándezF. GutiérrezE. MartínezIMPAC-NEO Study GroupBMCarticleHIV infectionNeoplasmsCancerNon-AIDS-defining cancersScreeningEarly detection of cancerMedicine (General)R5-920ENTrials, Vol 22, Iss 1, Pp 1-11 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	HIV infection Neoplasms Cancer Non-AIDS-defining cancers Screening Early detection of cancer Medicine (General) R5-920
spellingShingle	HIV infection Neoplasms Cancer Non-AIDS-defining cancers Screening Early detection of cancer Medicine (General) R5-920 M. Masiá S. Padilla G. Estañ J. Portu A. Silva A. Rivero A. González-Cordón L. García-Fraile O. Martínez E. Bernal C. Galera V. Boix Martínez J. Macias M. Montero D. García-Rosado M. J. Vivancos-Gallego J. Llenas-García M. Torralba J. A. García V. Agulló M. González-Fernández F. Gutiérrez E. Martínez IMPAC-NEO Study Group Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection
description	Abstract Background The incidence of non-AIDS defining cancer (NADC) is higher in people living with HIV (PLWH) than in the general population, and it is already one of the leading causes of death in the HIV-infected population. It is estimated that the situation will be aggravated by the progressive aging of PLWH. Early diagnosis through intensive cancer screening may improve the ability for therapeutic interventions and could be critical in reducing mortality, but it might also increase expenditure and harms associated with adverse events. The aim of this study is to evaluate an enhanced screening program for early diagnosis of cancer in PLWH compared to standard practice. The specific objectives are (1) to compare the frequency of cancer diagnosed at an early stage, (2) to analyze safety of the enhanced program: adverse events and unnecessary interventions, (3) to analyze the cost-utility of the program, and (4) to estimate the overall and site-specific incidence of NADC in PLWH. Methods We will conduct a multicenter, non-blinded, randomized, controlled trial, comparing two parallel arms: conventional vs enhanced screening. Data will be recorded in an electronic data collection notebook. Conventional intervention group will follow the standard of care screening in the participating centers, according to the European AIDS Clinical Society recommendations, and the enhanced intervention group will follow an expanded screening aimed to early detection of lung, liver, anal, cervical, breast, prostate, colorectal, and skin cancer. The trial will be conducted within the framework of the Spanish AIDS Research Network Cohort (CoRIS). Discussion The trial will evaluate the efficacy, safety, and efficiency of an enhanced screening program for the early diagnosis of cancer in HIV patients compared to standard of care practice. The information provided will be relevant since there are currently no studies on expanded cancer screening strategies in patients with HIV, and available data estimating cost effectiveness or cost-utility of such as programs are scarce. An enhanced program for NADC screening in patients with HIV could lead to early diagnosis and improve the prognosis of these patients, with an acceptable rate of unnecessary interventions, but it is critical to demonstrate that the benefits clearly outweigh the harms, before the strategy could be implemented. Trial registration ClinicalTrials.gov NCT04735445. Registered on 25 June 2019
format	article
author	M. Masiá S. Padilla G. Estañ J. Portu A. Silva A. Rivero A. González-Cordón L. García-Fraile O. Martínez E. Bernal C. Galera V. Boix Martínez J. Macias M. Montero D. García-Rosado M. J. Vivancos-Gallego J. Llenas-García M. Torralba J. A. García V. Agulló M. González-Fernández F. Gutiérrez E. Martínez IMPAC-NEO Study Group
author_facet	M. Masiá S. Padilla G. Estañ J. Portu A. Silva A. Rivero A. González-Cordón L. García-Fraile O. Martínez E. Bernal C. Galera V. Boix Martínez J. Macias M. Montero D. García-Rosado M. J. Vivancos-Gallego J. Llenas-García M. Torralba J. A. García V. Agulló M. González-Fernández F. Gutiérrez E. Martínez IMPAC-NEO Study Group
author_sort	M. Masiá
title	Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection
title_short	Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection
title_full	Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection
title_fullStr	Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection
title_full_unstemmed	Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection
title_sort	impact of an enhanced screening program on the detection of non-aids neoplasias in patients with human immunodeficiency virus infection
publisher	BMC
publishDate	2021
url	https://doaj.org/article/18d46939dfdc4e3592c6a450f8dfd747
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Impact of an enhanced screening program on the detection of non-AIDS neoplasias in patients with human immunodeficiency virus infection

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