Role of magnetic resonance imaging and serum markers CA-125 and HE-4 in the evaluation of indeterminate annexal masses according to conventional ultrasound. (Q3138749): Difference between revisions

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(‎Created claim: summary (P836): Ultrasound allows the majority of annexed masses to be characterised. However, a percentage of cases cannot be classified (indeterminate mass). In these cases, vlaorisation by an expert ultrasoundist, the use of magnetic resonance imaging (MRI) or the determination of tumor markers have been proposed. The objective of this prospective study is to investigate the impact of ultrasound evaluation by expert examiner, magnetic resonance imaging or t...)
(‎Changed label, description and/or aliases in en: translated_label)
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Role of magnetic resonance imaging and serum markers CA-125 and HE-4 in the evaluation of indeterminate annexal masses according to conventional ultrasound.

Revision as of 13:20, 12 October 2021

Project Q3138749 in Spain
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English
Role of magnetic resonance imaging and serum markers CA-125 and HE-4 in the evaluation of indeterminate annexal masses according to conventional ultrasound.
Project Q3138749 in Spain

    Statements

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    26,000.0 Euro
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    52,000.0 Euro
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    50.0 percent
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    1 January 2018
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    31 March 2021
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    FUNDACION INSTITUTO DE INVESTIGACION SANITARIA DE NAVARRA
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    42°49'6.42"N, 1°38'39.34"W
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    31201
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    La ecografía permite caracterizar la mayoría de masas anexiales. Sin embargo, un porcentaje de casos no pueden clasificarse (masas indeterminadas). En estos casos se ha propuesto la vlaoración por un ecografista experto, el uso de resonancia magnética (RM) o la determinación de marcadores tumorales. El objetivo del presente estudio prospectivo es investigar el impacto de la evaluación ecográfica por examinador experto, la resonancia magnética o el uso de marcadores tumorales en la toma de decisiones terapéuticas y los costos en el manejo de pacientes con una masa anexial indeterminada. Sólo las pacientes definidas como masa indeterminada según las IOTA “simple rules” serán incluidas en el estudio y sometidas a evaluación por ecografista experto, RM y a determinación de marcadores tumorales (CA-125 y HE-4). Las pacientes incluidas en el estudio serán sometidas a cirugía y el análisis histopatológico será el estándar de referencia. El rendimiento diagnóstico se evaluará mediante el cálculo de la sensibilidad, especificidad y las “likelihood ratio” positiva (LR +) y negativa (LR-) de la propuesta de diagrama de flujo de diagnóstico. También se realizará un análisis costo-beneficio de cada una de las alternativas de triage. (Spanish)
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    Ultrasound allows the majority of annexed masses to be characterised. However, a percentage of cases cannot be classified (indeterminate mass). In these cases, vlaorisation by an expert ultrasoundist, the use of magnetic resonance imaging (MRI) or the determination of tumor markers have been proposed. The objective of this prospective study is to investigate the impact of ultrasound evaluation by expert examiner, magnetic resonance imaging or the use of tumor markers on therapeutic decision-making and the costs in the management of patients with an indeterminate annexal mass. Only patients defined as an indeterminate mass according to the “simple rules” IOTA will be included in the study and subjected to expert ultrasound evaluation, MRI and tumor marker determination (CA-125 and HE-4). Patients included in the study will undergo surgery and histopathological analysis will be the standard of reference. Diagnostic performance will be evaluated by calculating the sensitivity, specificity, positive (LR+) and negative (LR-) likelihood ratios (LR-) of the proposed diagnostic flowchart. A cost-benefit analysis of each of the triage alternatives will also be carried out. (English)
    12 October 2021
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    Pamplona/Iruña
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    Identifiers

    PI17_01326
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