Q3137637 (Q3137637): Difference between revisions
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(Created claim: summary (P836): Introduction: Human papillomavirus (HPV) infection and the development of anal cancer (AC) is a growing pathology in men who have sex with men (HSH) infected with human immunodeficiency virus (HIV) and represents a public health problem. However, there are still no standardised criteria for CA screening. High-risk HPV (HR) infection has a very high prevalence in this group and cytology has not shown sufficient sensitivity and specificity in the...) |
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Introduction: Human papillomavirus (HPV) infection and the development of anal cancer (AC) is a growing pathology in men who have sex with men (HSH) infected with human immunodeficiency virus (HIV) and represents a public health problem. However, there are still no standardised criteria for CA screening. High-risk HPV (HR) infection has a very high prevalence in this group and cytology has not shown sufficient sensitivity and specificity in the selection of patients who need more invasive testing.Objectives: 1)evaluate the negative and positive predictive value of mRNA expression of E6/E7 oncoproteins for high-grade lesions (HSIL) annals and their ability to predict the incidence of new HSIL over a follow-up period of between 2 and 5 years. 2)Analyse the cost-effectiveness of the anal cancer screening strategy based on the selection of patients candidates for high resolution anoscopy (HRA) according to the expression of mRNA of E6/E7 compared to the usual strategy based on cytology and detection of HPV-AR DNA. Methodology: longitudinal ambispective study.HIV-positive HSH patients will be included. At each visit, anal smears will be performed for cytological study, HPV-AR DNA detection, mRNA detection of E6/E7 and HRA proteins. The patients who will be proposed to study will be i) patients who have already been visited within the usual practice in our CA screening cabinet since January 2015 and for whom an anal cytology sample has been stored ii) patients who initiate follow-up in the study. This in order to reduce the inclusion time and maximise the follow-up time of the study population. The cost-effectiveness analysis will be carried out using a Markov model that will project in the long term the costs and effectiveness of the strategy based on the E6/E7 mRNA biomarker and the conventional strategy. (English) | |||||||||||||||
| Property / summary: Introduction: Human papillomavirus (HPV) infection and the development of anal cancer (AC) is a growing pathology in men who have sex with men (HSH) infected with human immunodeficiency virus (HIV) and represents a public health problem. However, there are still no standardised criteria for CA screening. High-risk HPV (HR) infection has a very high prevalence in this group and cytology has not shown sufficient sensitivity and specificity in the selection of patients who need more invasive testing.Objectives: 1)evaluate the negative and positive predictive value of mRNA expression of E6/E7 oncoproteins for high-grade lesions (HSIL) annals and their ability to predict the incidence of new HSIL over a follow-up period of between 2 and 5 years. 2)Analyse the cost-effectiveness of the anal cancer screening strategy based on the selection of patients candidates for high resolution anoscopy (HRA) according to the expression of mRNA of E6/E7 compared to the usual strategy based on cytology and detection of HPV-AR DNA. Methodology: longitudinal ambispective study.HIV-positive HSH patients will be included. At each visit, anal smears will be performed for cytological study, HPV-AR DNA detection, mRNA detection of E6/E7 and HRA proteins. The patients who will be proposed to study will be i) patients who have already been visited within the usual practice in our CA screening cabinet since January 2015 and for whom an anal cytology sample has been stored ii) patients who initiate follow-up in the study. This in order to reduce the inclusion time and maximise the follow-up time of the study population. The cost-effectiveness analysis will be carried out using a Markov model that will project in the long term the costs and effectiveness of the strategy based on the E6/E7 mRNA biomarker and the conventional strategy. (English) / rank | |||||||||||||||
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| Property / summary: Introduction: Human papillomavirus (HPV) infection and the development of anal cancer (AC) is a growing pathology in men who have sex with men (HSH) infected with human immunodeficiency virus (HIV) and represents a public health problem. However, there are still no standardised criteria for CA screening. High-risk HPV (HR) infection has a very high prevalence in this group and cytology has not shown sufficient sensitivity and specificity in the selection of patients who need more invasive testing.Objectives: 1)evaluate the negative and positive predictive value of mRNA expression of E6/E7 oncoproteins for high-grade lesions (HSIL) annals and their ability to predict the incidence of new HSIL over a follow-up period of between 2 and 5 years. 2)Analyse the cost-effectiveness of the anal cancer screening strategy based on the selection of patients candidates for high resolution anoscopy (HRA) according to the expression of mRNA of E6/E7 compared to the usual strategy based on cytology and detection of HPV-AR DNA. Methodology: longitudinal ambispective study.HIV-positive HSH patients will be included. At each visit, anal smears will be performed for cytological study, HPV-AR DNA detection, mRNA detection of E6/E7 and HRA proteins. The patients who will be proposed to study will be i) patients who have already been visited within the usual practice in our CA screening cabinet since January 2015 and for whom an anal cytology sample has been stored ii) patients who initiate follow-up in the study. This in order to reduce the inclusion time and maximise the follow-up time of the study population. The cost-effectiveness analysis will be carried out using a Markov model that will project in the long term the costs and effectiveness of the strategy based on the E6/E7 mRNA biomarker and the conventional strategy. (English) / qualifier | |||||||||||||||
point in time: 12 October 2021
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Revision as of 12:35, 12 October 2021
Project Q3137637 in Spain
| Language | Label | Description | Also known as |
|---|---|---|---|
| English | No label defined |
Project Q3137637 in Spain |
Statements
68,000.0 Euro
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136,000.0 Euro
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50.0 percent
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1 January 2017
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31 March 2020
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INSTITUTO DE INVESTIGACION BIOMEDICA DE BELLVITGE
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41°21'35.50"N, 2°5'59.24"E
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08101
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Introducción:La infección por el virus del papiloma humano (VPH) y el desarrollo de cáncer anal (CA) es una patología creciente en hombres que tienen sexo con hombres (HSH) infectados por el virus de la inmunodeficiencia humana (VIH) y representa un problema de salud pública.Sin embargo, todavía no existen criterios estandarizados de cribado de CA. La infección por VPH de alto riesgo (AR) tiene una prevalencia muy elevada en este colectivo y la citología no ha mostrado suficiente sensibilidad y especificidad en la selección de pacientes que necesitan pruebas más invasivas.Objetivos: 1)evaluar el valor predictivo negativo y positivo de la expresión ARNm de las oncoproteinas E6/E7 para lesiones de alto grado (HSIL) anales y su capacidad de predecir la incidencia de nuevas HSIL durante un periodo de seguimiento de entre 2 y 5 años. 2)Analizar el coste-efectividad de la estrategia de cribado de cáncer anal basada en la selección de pacientes candidatos a anoscopia de alta resolución (HRA) según la expresión de ARNm de E6/E7 comparado con la estrategia habitual basada en la citología y detección de ADN de VPH-AR. Metodología: estudio ambispectivo longitudinal.Se incluirán pacientes HSH VIH positivos. En cada visita se realizarán frotis anal para estudio citológico, detección de DNA de VPH-AR, detección de ARNm de las proteinas E6/E7 y HRA. Los pacientes a los que se les propondrá el estudio serán i) pacientes que ya han sido visitados dentro de la práctica habitual en nuestro gabinete de cribado de CA desde Enero 2015 y para los que se ha almacenado una muestra de citología anal ii) pacientes que inicien el seguimiento en el estudio. Esto con el fin de reducir el tiempo de inclusión y maximizar el tiempo de seguimiento de la población de estudio. El análisis de coste-efectividad se realizará mediante un modelo de Markov que proyectará a largo plazo los costes y la efectividad de la estrategia basada en el biomarcador ARNm de E6/E7 y de la estrategia convencional. (Spanish)
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Introduction: Human papillomavirus (HPV) infection and the development of anal cancer (AC) is a growing pathology in men who have sex with men (HSH) infected with human immunodeficiency virus (HIV) and represents a public health problem. However, there are still no standardised criteria for CA screening. High-risk HPV (HR) infection has a very high prevalence in this group and cytology has not shown sufficient sensitivity and specificity in the selection of patients who need more invasive testing.Objectives: 1)evaluate the negative and positive predictive value of mRNA expression of E6/E7 oncoproteins for high-grade lesions (HSIL) annals and their ability to predict the incidence of new HSIL over a follow-up period of between 2 and 5 years. 2)Analyse the cost-effectiveness of the anal cancer screening strategy based on the selection of patients candidates for high resolution anoscopy (HRA) according to the expression of mRNA of E6/E7 compared to the usual strategy based on cytology and detection of HPV-AR DNA. Methodology: longitudinal ambispective study.HIV-positive HSH patients will be included. At each visit, anal smears will be performed for cytological study, HPV-AR DNA detection, mRNA detection of E6/E7 and HRA proteins. The patients who will be proposed to study will be i) patients who have already been visited within the usual practice in our CA screening cabinet since January 2015 and for whom an anal cytology sample has been stored ii) patients who initiate follow-up in the study. This in order to reduce the inclusion time and maximise the follow-up time of the study population. The cost-effectiveness analysis will be carried out using a Markov model that will project in the long term the costs and effectiveness of the strategy based on the E6/E7 mRNA biomarker and the conventional strategy. (English)
12 October 2021
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Hospitalet de Llobregat, L'
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Identifiers
PI16_01056
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