- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio 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
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
-
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National Capital Region
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Quezon City, National Capital Region, Filipinas, 1102
- Philippine Urological Association Inc.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
New patient presented with prostate disease
prostate disease identified
|
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)
Prazo: 1 year
|
number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Prevalence of Prostate Diseases
Prazo: 1 year
|
total number of patient consulted on Pa-DRE ka day with prostate diseases
|
1 year
|
|
International Prostate Symptom Score
Prazo: 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
Prazo: 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
Prazo: 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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PURA-2013
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