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
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
National Capital Region
-
Quezon City、National Capital Region、フィリピン、1102
- Philippine Urological Association Inc.
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
---|---|
New patient presented with prostate disease
prostate disease identified
|
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Incidence of Prostate disease (benign prostatic hyperplasia, prostatitis, Prostate cancer)
時間枠:1 year
|
number of new diagnosed prostate disease (target population) for Pa-DRE ka day screening program.
|
1 year
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Prevalence of Prostate Diseases
時間枠:1 year
|
total number of patient consulted on Pa-DRE ka day with prostate diseases
|
1 year
|
International Prostate Symptom Score
時間枠: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
時間枠: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
時間枠:1 year
|
Summary of digital rectal exam findings of patients presented to prostate screening program (Pa-DRE ka day)
|
1 year
|
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Prostate health screeningの臨床試験
-
Alfonso Gomez-IturriagaHospital de Crucesわからない
-
Radicle Science積極的、募集していない
-
Northwestern UniversityUnited States Department of Defense募集
-
Boston Children's HospitalUnited States Department of Defense; National Football League完了
-
Johns Hopkins UniversityApple Inc.; iHealth完了
-
University of Texas Southwestern Medical CenterVivify Health引きこもった