- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01886547
2013 Annual National Digital Rectal Exam (DRE) Day Study
2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Convenience sampling method will be applied to collect all completed Philippine Urological Association (PUA) survey forms from the 11 Philippine Board of Urology accredited training institutions. A data collection form for the purpose of this study will be used to extract data from the Philippine Urological Association survey forms. The data collection form for this study will extract data, which include basic demographic characteristics of the patients (such as age and educational attainment), family history of prostate cancer, other medical conditions, history of prior prostate screening/ consultation for Lower urinary tract Symptoms or prostate disease. The International Prostate Symptom scores (IPSS) collected will be stratified according to mild (1-7), moderate (8-19) and severe (20-35) and the Filipino version Quality of Life (QoL) ratings will be stratified according to Grade 1, grade 2 and grade 3. DRE findings including the approximation of prostate size and prostate characteristic findings will be clustered to normal in size (20grams or less) versus enlarged (>20grams or 2 fingerbreadths in width), nodular vs non-nodular, doughy or hard, and tender versus non-tender.
Participants will be classified according to the following :
Target population for screening or not :
Target population for screening is defined as Filipino males aged 40 years or older, who also had no previous consultation for Lower urinary tract symptoms (LUTS) or prostate cancer screening in the past 12 months
- Case Finding for significant LUTS or prostate cancer or not :
Case of LUTS or prostate cancer is defined as Filipino males aged 40 years or older with IPSS > 8, OR, has abnormal Digital rectal exam (DRE) finding, which is defined as nodular OR hard OR tender. However, DRE finding of an enlarged prostate but non-nodular, doughy in character and non-tender will not be considered as a case of LUTS or prostate cancer suspect).
Confidentiality of all data will be assured. The case report forms/ data collection form for this study will not contain any patient identifiers. All patient records will be coded in the electronic database as serial number and PUA-designated Institutional code (i.e. SLMC #0001). Only the investigators of this study and other authorized personnel from PUA will be given access to the study data. The PUA survey forms will be secured, filed and only accessed in PUA secretariat building. The electronic database coded with the data from the data collection from of this study will be set with password, and only the study investigators have access to the password.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
National Capital Region
-
Quezon City, National Capital Region, Filipinas, 1102
- Philippine Urological Association Inc.
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Filipino male ages 40 or older consulted on "Pa-DRE ka" prostate health screening program 2013
- patients presented to the Philippine Board of Urology accredited 11 training institutions
- Consented for the screening program.
- Completed the questionnaire of International Prostate symptoms score
- Has been examined with digital rectal examination
Exclusion Criteria:
- Patients who have incomplete data and did not consent for the screening program
- Non-Filipino male patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
---|---|
New patient presented with prostate disease
prostate disease identified
|
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)
Periodo de tiempo: 1 year
|
number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.
|
1 year
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Prevalence of Prostate Diseases
Periodo de tiempo: 1 year
|
total number of patient consulted on Pa-DRE ka day with prostate diseases
|
1 year
|
International Prostate Symptom Score
Periodo de tiempo: 1 year
|
Total score of international Prostate Symptoms Score of each patients consulted for Prostate screening program (Pa-DRE ka day)
|
1 year
|
Prostate gland size estimate
Periodo de tiempo: 1 year
|
Estimated prostate gland size by digital rectal exam for patients presented to the prostate screening program (Pa-DRE ka day)
|
1 year
|
Digital rectal examination result
Periodo de tiempo: 1 year
|
Summary of digital rectal exam findings of patients presented to prostate screening program (Pa-DRE ka day)
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PURA-2013
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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