UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001313 |
|---|---|
| Receipt number | R000001596 |
| Scientific Title | Clinical significance of novel urinary markers for the diagnosis, staging, and the prediction of prognosis in patients with prostate cancer |
| Date of disclosure of the study information | 2008/08/14 |
| Last modified on | 2009/06/28 13:56:33 |
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Basic information
Public title
Clinical significance of novel urinary markers for the diagnosis, staging, and the prediction of prognosis in patients with prostate cancer
Acronym
Clinical significance of novel urinary markers in prostate cancer
Scientific Title
Clinical significance of novel urinary markers for the diagnosis, staging, and the prediction of prognosis in patients with prostate cancer
Scientific Title:Acronym
Clinical significance of novel urinary markers in prostate cancer
Region
| Japan |
Condition
Condition
Prostate cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It would be economically of great benefit to find predictors for prostate cancer diagnosis, staging, and prognosis more accurately. The aim of our study is to evaluate the utility of urinary marker such as PCA3, PSA-related marker, and AMACR for improving prostate cancer diagnosis, staging, and prediction of prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the association between urinary markers and 1)presence or absence of prostate cancer, 2)cinical staging, 3)pathological staging (TNM clasification), 4)PSA recurrence, and 5)prognosis
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male
Key inclusion criteria
The patients who undergo needle biopsy of the prostate and the patients who diagnosed as prostate cancer
Key exclusion criteria
The patients who do not have anus because prostate massage is not possible during the procedure to get samples
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Eiji Kikuchi |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi Shinjuku-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
TEL
03-5363-3825
Homepage URL
Sponsor or person
Institute
Department of Urology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2008 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2009 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2009 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2009 | Year | 06 | Month | 01 | Day |
Other
Other related information
Case control sampling and prospective study
Management information
Registered date
| 2008 | Year | 08 | Month | 13 | Day |
Last modified on
| 2009 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001596
