Study of the adequacy of serum prostate antigen (PSA) requests, factors associated with the presence of false negatives and positives and impact on the patient’s health. (Q3142554)

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Project Q3142554 in Spain
Language Label Description Also known as
English
Study of the adequacy of serum prostate antigen (PSA) requests, factors associated with the presence of false negatives and positives and impact on the patient’s health.
Project Q3142554 in Spain

    Statements

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    39,375.0 Euro
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    78,750.0 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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    UNIVERSIDAD MIGUEL HERNANDEZ
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    38°20'37.10"N, 0°29'17.41"W
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    03014
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    Objetivos: Evaluar las características de la determinación del PSA para la detección precoz del cáncer de próstata o ante la presencia de síntomas, en la práctica general en dos departamentos de salud de la Comunidad Valenciana, así como los factores clínicos y analíticos (nivel de PSA) asociados a la presencia de resultados falsos positivos y falsos negativos y el proceso diagnóstico/terapéutico seguido por dichos pacientes. Metodología: Se llevará a cabo un estudio transversal para evaluar la adecuación de las determinaciones de PSA a las recomendaciones disponibles y sus variables asociadas (2.144 pacientes). Se incluirá también un estudio de cohortes prospectivo formado por una muestra de pacientes con resultado positivo de PSA (2.155 pacientes) y otra cohorte de resultados negativos (1.679 pacientes) y se seguirá durante 2 años mediante la revisión de historias clínicas. Se determinará la presencia y variables asociadas a los resultados falsos negativos y positivos, así como las características del manejo de estos pacientes. Se incluirán pacientes con una determinación del PSA en los Dept de Salud número 19 y 17 de la Comunidad Valenciana. Se excluirán aquellos pacientes que hayan sido diagnosticados previamente de cáncer de próstata o en seguimiento por valores elevados de PSA. (Spanish)
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    Objectives: Evaluate the characteristics of the PSA determination for the early detection of prostate cancer or the presence of symptoms, in general practice in two health departments of the Valencian Community, as well as the clinical and analytical factors (PSA level) associated with the presence of false positive and false negative results and the diagnostic/therapeutic process followed by these patients. Methodology: A cross-sectional study will be conducted to evaluate the adequacy of PSA determinations to the available recommendations and their associated variables (2,144 patients). A prospective cohort study consisting of a sample of patients with a positive PSA result (2,155 patients) and another cohort of negative results (1,679 patients) will also be included and followed for 2 years by review of medical records. The presence and variables associated with false negative and positive results, as well as the characteristics of the management of these patients, will be determined. Patients with a PSA determination will be included in Health Depts 19 and 17 of the Valencian Community. Patients who have previously been diagnosed with prostate cancer or are monitored by elevated PSA values should be excluded. (English)
    12 October 2021
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    Alicante/Alacant
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    Identifiers

    PI17_01883
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