UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011569 |
|---|---|
| Receipt number | R000013532 |
| Scientific Title | Levels of urinary OAB biomarker and voiding symptom score in bladder cancer patients recieving intravesical BCG therapy |
| Date of disclosure of the study information | 2013/09/01 |
| Last modified on | 2018/02/26 16:35:09 |
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Basic information
Public title
Levels of urinary OAB biomarker and voiding symptom score in bladder cancer patients recieving intravesical BCG therapy
Acronym
Urinary biomarker study of BCG-induced OAB
Scientific Title
Levels of urinary OAB biomarker and voiding symptom score in bladder cancer patients recieving intravesical BCG therapy
Scientific Title:Acronym
Urinary biomarker study of BCG-induced OAB
Region
| Japan |
Condition
Condition
overactive bladder
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the urinary OAB biomarkers which correlates with voiding symptom scores in patients recieving intravesical BCG therapy
Basic objectives2
Others
Basic objectives -Others
biomarker study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Validated questionnaire such as OABSS, IPSS and CLSS.
Urinary NGF and BDNF levels.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
High-risk nonmuscle-invasive bladder cancer patients receiving intravesical BCG therapy after TURBT
Key exclusion criteria
Residual urine >100ml
Urinary infection
Gross hematuria
Target sample size
40
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, Shinjyuku, Tokyo
TEL
03-3353-1211
eiji-k@kb3.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsura Ishioka |
Organization
Keio University School of Medicine
Division name
Department of Urology
Zip code
Address
35 Shinanomachi, Shinjyuku, Tokyo
TEL
03-3353-1211
Homepage URL
katsuran-h@a5.keio.jp
Sponsor or person
Institute
Keio University School of Medicine,
Department of Urology
Institute
Department
Personal name
Funding Source
Organization
Keio University School of Medicine,
Department of Urology
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
| 2013 | Year | 09 | Month | 01 | 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
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
terminated
Management information
Registered date
| 2013 | Year | 08 | Month | 23 | Day |
Last modified on
| 2018 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013532
