- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
-
-
National Capital Region
-
Quezon City, National Capital Region, Philippinen, 1102
- Philippine Urological Association Inc.
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
---|---|
New patient presented with prostate disease
prostate disease identified
|
Andere Namen:
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)
Zeitfenster: 1 year
|
number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.
|
1 year
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Prevalence of Prostate Diseases
Zeitfenster: 1 year
|
total number of patient consulted on Pa-DRE ka day with prostate diseases
|
1 year
|
International Prostate Symptom Score
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 1 year
|
Summary of digital rectal exam findings of patients presented to prostate screening program (Pa-DRE ka day)
|
1 year
|
Mitarbeiter und Ermittler
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- PURA-2013
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .
Klinische Studien zur Prostate health screening
-
University of California, San FranciscoSeva Foundation; Bharatpur Eye HospitalAbgeschlossenGlaukom | Diabetische Retinopathie | Brechungsfehler | Katarakt | Altersbedingte MakuladegenerationNepal
-
LMU KlinikumPreventicus GmbH; Versicherungskammer BayernAktiv, nicht rekrutierend
-
Fresenius Medical Care North AmericaMedical Nutrition USA, Inc.Beendet
-
University of ArkansasNational Institute on Minority Health and Health Disparities (NIMHD); Virginia... und andere MitarbeiterNoch keine RekrutierungEinstellungen | Wissen | VerhaltensabsichtVereinigte Staaten
-
Ondokuz Mayıs UniversityAbgeschlossen
-
Brigham and Women's HospitalAbgeschlossenScheinbarer Mineralocorticoid-Exzess (AME)Vereinigte Staaten
-
IWK Health CentreNoch keine Rekrutierung
-
Radicle ScienceAktiv, nicht rekrutierendBauchschmerzen | Verdauung | GI-StörungenVereinigte Staaten
-
Manan ShuklaAbgeschlossenAsthma | Chronische ErkrankungVereinigte Staaten
-
Boston UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... und andere MitarbeiterRekrutierungStillen | SUID | SIDSVereinigte Staaten