Impact of an Expanded Screening Program on the detection of non-AIDS neoplasms in patients with Human Immunodeficiency Virus (HIV) infection. IMPAC-NEO. (Q3148738): Difference between revisions

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(‎Changed label, description and/or aliases in en: translated_label)
(‎Removed claim: summary (P836): Objectives: Evaluate the effectiveness, safety and efficiency of an expanded screening programme for early cancer diagnosis in HIV patients compared to standard practice within the cohort of the National AIDS Research Network (CoRIS). Method: Interventional clinical trial. Randomisation stratified by center, according to the number of patients, to one of the following groups: 1) Enlarged intervention group: expanded screening for early detec...)
Property / summary
Objectives: Evaluate the effectiveness, safety and efficiency of an expanded screening programme for early cancer diagnosis in HIV patients compared to standard practice within the cohort of the National AIDS Research Network (CoRIS). Method: Interventional clinical trial. Randomisation stratified by center, according to the number of patients, to one of the following groups: 1) Enlarged intervention group: expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal, and skin cancers; and 2) Conventional Intervention Group: routine screening in participating centres, according to the criteria of the European AIDS Society (EACS). The primary analysis will be the comparison of the number of cancers diagnosed in both groups following the principle of intention to screen. A sample size of 2899 patients has been calculated in each group (expected cancer incidence 2 % and 1 % in groups 1 and 2; 80 % power; losses 20 %) A protocol analysis will also be performed on a secondary basis. Secondary safety analysis will compare the number of unnecessary invasive procedures in both groups and mortality from cancer and any cause. The secondary cost-utility analysis will be carried out following recommendations from the guide for the economic evaluation of health technologies in Spain from the perspective of the National Health System (SNS). Cost-effectiveness and incremental cost-effectiveness ratios shall be calculated. (English)
 
Property / summary: Objectives: Evaluate the effectiveness, safety and efficiency of an expanded screening programme for early cancer diagnosis in HIV patients compared to standard practice within the cohort of the National AIDS Research Network (CoRIS). Method: Interventional clinical trial. Randomisation stratified by center, according to the number of patients, to one of the following groups: 1) Enlarged intervention group: expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal, and skin cancers; and 2) Conventional Intervention Group: routine screening in participating centres, according to the criteria of the European AIDS Society (EACS). The primary analysis will be the comparison of the number of cancers diagnosed in both groups following the principle of intention to screen. A sample size of 2899 patients has been calculated in each group (expected cancer incidence 2 % and 1 % in groups 1 and 2; 80 % power; losses 20 %) A protocol analysis will also be performed on a secondary basis. Secondary safety analysis will compare the number of unnecessary invasive procedures in both groups and mortality from cancer and any cause. The secondary cost-utility analysis will be carried out following recommendations from the guide for the economic evaluation of health technologies in Spain from the perspective of the National Health System (SNS). Cost-effectiveness and incremental cost-effectiveness ratios shall be calculated. (English) / rank
Normal rank
 
Property / summary: Objectives: Evaluate the effectiveness, safety and efficiency of an expanded screening programme for early cancer diagnosis in HIV patients compared to standard practice within the cohort of the National AIDS Research Network (CoRIS). Method: Interventional clinical trial. Randomisation stratified by center, according to the number of patients, to one of the following groups: 1) Enlarged intervention group: expanded screening for early detection of lung, liver, anal, cervical, breast, prostate, colorectal, and skin cancers; and 2) Conventional Intervention Group: routine screening in participating centres, according to the criteria of the European AIDS Society (EACS). The primary analysis will be the comparison of the number of cancers diagnosed in both groups following the principle of intention to screen. A sample size of 2899 patients has been calculated in each group (expected cancer incidence 2 % and 1 % in groups 1 and 2; 80 % power; losses 20 %) A protocol analysis will also be performed on a secondary basis. Secondary safety analysis will compare the number of unnecessary invasive procedures in both groups and mortality from cancer and any cause. The secondary cost-utility analysis will be carried out following recommendations from the guide for the economic evaluation of health technologies in Spain from the perspective of the National Health System (SNS). Cost-effectiveness and incremental cost-effectiveness ratios shall be calculated. (English) / qualifier
point in time: 12 October 2021
Timestamp+2021-10-12T00:00:00Z
Timezone+00:00
CalendarGregorian
Precision1 day
Before0
After0
 

Revision as of 15:08, 12 October 2021

Project Q3148738 in Spain
Language Label Description Also known as
English
Impact of an Expanded Screening Program on the detection of non-AIDS neoplasms in patients with Human Immunodeficiency Virus (HIV) infection. IMPAC-NEO.
Project Q3148738 in Spain

    Statements

    country
    Spain
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    EU contribution
    91,000.0 Euro
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    budget
    182,000.0 Euro
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    co-financing rate
    50.0 percent
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    start time
    1 January 2019
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    end time
    31 March 2022
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    beneficiary name (string)
    FUNDACION PARA EL FOMENTO DE LA INV. SANITARIA Y BIOMEDICA DE LA COMUNIDAD VALENCIANA (FISABIO)
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    beneficiary
    Q3136692
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    coordinate location

    38°15'55.19"N, 0°41'55.82"W
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    postal code
    03065
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    summary
    Objetivos: Evaluar la eficacia, seguridad y eficiencia de un programa ampliado de cribado para el diagnóstico precoz de cáncer en pacientes con VIH en comparación con la práctica habitual, en el marco de la cohorte de la Red Nacional de Investigación en Sida (CoRIS). Método: Ensayo clínico de intervención. Aleatorización estratificada por centros, según el número de pacientes, a uno de los siguientes grupos: 1) Grupo de intervención ampliada: cribado ampliado para la detección precoz de cáncer de pulmón, hepático, anal, cervical, de mama, próstata, colorrectal y piel; y 2) Grupo de intervención convencional: cribado habitual en los centros participantes, ajustado a los criterios de la Sociedad Europea de SIDA (EACS). El análisis primario será la comparación del número de cánceres diagnosticados en ambos grupos siguiendo el principio de intención de cribar. Se ha calculado un tamaño muestral de 2899 pacientes en cada grupo (incidencia de cáncer esperada 2% y 1% en grupos 1 y 2; potencia 80%; pérdidas 20%) Se realizará también de manera secundaria un análisis por protocolo. El análisis secundario de seguridad comparará el número de procedimientos invasivos innecesarios en ambos grupos y la mortalidad por cáncer y por cualquier causa. El análisis secundario de coste-utilidad se realizará siguiendo recomendaciones de la guía para la evaluación económica de las tecnologías sanitarias en España bajo la perspectiva del Sistema Nacional de Salud (SNS). Se calcularán los cocientes coste-efectividad y coste-efectividad incremental. (Spanish)
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    location (string)
    Elche/Elx
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    Identifiers

    Spanish Kohesio ID
    PI18_01861
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