UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009508 |
|---|---|
| Receipt number | R000011018 |
| Scientific Title | Prevention of TaT1 bladder cancer by BCG instillation: Induction alone versus induction and maintenance |
| Date of disclosure of the study information | 2012/12/10 |
| Last modified on | 2014/09/15 11:33:05 |
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Basic information
Public title
Prevention of TaT1 bladder cancer by BCG instillation: Induction alone versus induction and maintenance
Acronym
Randomized control study of prevention bladder cancer recurrence between BCG induction alone and BCG induction + maintenance
Scientific Title
Prevention of TaT1 bladder cancer by BCG instillation: Induction alone versus induction and maintenance
Scientific Title:Acronym
Randomized control study of prevention bladder cancer recurrence between BCG induction alone and BCG induction + maintenance
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the efficacy and safety of BCG induction and maintenance compared to induction alone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Progression free survival, (time to progression)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
BCG instillation into the bladder induction
Interventions/Control_2
BCG instillation into the bladder induction and maintenance
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) pathologically confirmed recurrent TaT1 bladder cancer
2) pathologically confirmed first TaT1 bladder cancer, but excluding the exclusion criteria 1)
3) age from 20 years old to 80 years old
4) PS 0-1
5) 2nd TUR-Bt is required for pT1 cases.
Key exclusion criteria
1) first diagnosed Ta bladder cancer, and solitary, and less than 1cm, and urine cytology negative, and with CIS (carcinoma in situ)
2) past history of BCG instillation
3)1) error correction
Urine cytology positive after TUR-Bt is excluded.
pTa and solitary is excluded.
With CIS is excluded.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hidefumi Kinoshita |
Organization
Kansai Medical University
Division name
Department of Urology and Andrology
Zip code
Address
2-3-1 Shin-machi, Hirakata city, Osaka, Japan
TEL
072-804-0101
kinoshih@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hidefumi Kinoshita |
Organization
Kansai Medical University
Division name
Department of Urology and Andrology
Zip code
Address
2-3-1 Shin-machi, Hirakata, Osaka, Japan
TEL
072-804-0101
Homepage URL
kinoshih@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Urology and Andrology, Kansai Medical university
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2012 | Year | 12 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 09 | Day |
Last modified on
| 2014 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011018
