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2013 Annual National Digital Rectal Exam (DRE) Day Study

5. april 2015 opdateret af: Michael E. Chua, St. Luke's Medical Center, Philippines

2013 Annual National Digital Rectal Exam (DRE) Day: Impact on Prostate Health Awareness and Disease Detection

We aim to determine the effectiveness of 2013 "Mag paDRE ka" programme in increasing general public awareness on prostate health and promoting prostate health assessment among Filipino males aged 40 or older.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

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 :

  1. 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

  2. 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

925

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • National Capital Region
      • Quezon City, National Capital Region, Filippinerne, 1102
        • Philippine Urological Association Inc.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

40 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Han

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Filipino males ages 40 or older

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
New patient presented with prostate disease
prostate disease identified
Andre navne:
  • Digital rectal examination, International prostate symptoms score quetionnaire

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)
Tidsramme: 1 year
number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.
1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Prevalence of Prostate Diseases
Tidsramme: 1 year
total number of patient consulted on Pa-DRE ka day with prostate diseases
1 year
International Prostate Symptom Score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 1 year
Summary of digital rectal exam findings of patients presented to prostate screening program (Pa-DRE ka day)
1 year

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2013

Primær færdiggørelse (Faktiske)

1. oktober 2014

Studieafslutning (Faktiske)

1. oktober 2014

Datoer for studieregistrering

Først indsendt

23. juni 2013

Først indsendt, der opfyldte QC-kriterier

23. juni 2013

Først opslået (Skøn)

26. juni 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

7. april 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. april 2015

Sidst verificeret

1. april 2015

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • PURA-2013

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Benign prostatahyperplasi

Kliniske forsøg med Prostate health screening

Abonner