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

Acquired Immunodeficiency Syndrome Early Detection of Cancer HIV Infections / complications Humans Male Mass Screening Neoplasms / diagnosis

Cancer Early detection of cancer HIV infection Neoplasms Non-AIDS-defining cancers Screening

Journal

Trials

ISSN: 1745-6215

Titre abrégé: Trials

Pays: England

ID NLM: 101263253

Informations de publication

Date de publication:
27 Nov 2021

Historique:

received: 09 03 2021

accepted: 29 10 2021

entrez: 28 11 2021

pubmed: 29 11 2021

medline: 1 12 2021

Statut: epublish

Résumé

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. 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). 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. ClinicalTrials.gov NCT04735445. Registered on 25 June 2019.

Sections du résumé

BACKGROUND BACKGROUND

METHODS 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 CONCLUSIONS

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 BACKGROUND

ClinicalTrials.gov NCT04735445. Registered on 25 June 2019.

Identifiants

DOI: 10.1186/s13063-021-05777-6 PMID: 34838115 PMC: PMC8626748

pubmed: 34838115

doi: 10.1186/s13063-021-05777-6

pii: 10.1186/s13063-021-05777-6

pmc: PMC8626748

doi:

Banques de données

ClinicalTrials.gov

['NCT04735445']

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial

Langues

eng

Sous-ensembles de citation

Pagination

851

Subventions

Organisme : Instituto de Salud Carlos III

ID : PI18/01861

Investigateurs

Antonia Alcaraz-García (A)

Ana Caicedo (A)

Alexy Inciarte (A)

Alfredo Espinosa (A)

Ana López-Lirola (A)

Concha Amador (C)

Ana Silva (A)

Antonio Navarro (A)

Ángela Camacho (Á)

Aurora Pérez (A)

Carlos Galera (C)

Melissa Carreres (M)

Camila Piatti (C)

David Vinuesa (D)

David Dalmau (D)

Dácil García-Rosado (D)

Marcos Diez-Martinez (M)

Daniel Podzamczer (D)

Ester Saez (E)

Esther Fagúndez-Reloba (E)

Federico García (F)

Juan Flores (J)

Gema García (G)

Javier García-Abellán (J)

Lucía Guillén (L)

Gema Navarro (G)

Inma González-Cuello (I)

Helena Albendín (H)

Inmaculada Ruiz-Cáceres (I)

Isabel Machuca (I)

Ignacio Santos (I)

Itziar Sobron (I)

Juan Emilio Losa (JE)

Juan Luis Gómez-Sirvent (JL)

Jose Ramon Blanco (JR)

Juan Macías (J)

Juan Carlos Gainzarai (JC)

Lorena Martínez (L)

Josep Mallolas (J)

María Del Mar Alonso-Socas (MDM)

Belén Martínez-López (B)

Araceli Fernández (A)

María Jehovana Hernández-Rodríguez (MJ)

Miguel Angel Moran (MA)

Marta Navarro (M)

Reyes Pascual (R)

Francisco Pasquau (F)

Pilar Callau (P)

Joaquín Portilla (J)

Catalina Robledano (C)

Jhon Rojas (J)

Ricardo Pelazas (R)

Sandra Cuellar (S)

Santos Del Campo (S)

Sonia Calzado (S)

Santiago Moreno (S)

Sofía Scévola (S)

Guillemo Telenti (G)

Zuriñe Ortiz (Z)

Commentaires et corrections

Type : ErratumIn

Informations de copyright

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