UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004672 |
|---|---|
| Receipt number | R000005565 |
| Scientific Title | Therapeutic effect of Intravesical Bacillus Calmette-Guerin(IMMUCYST) to nonmuscle-invasive urothelial carcinoma of bladder and examination of safety |
| Date of disclosure of the study information | 2010/12/08 |
| Last modified on | 2012/01/22 18:02:29 |
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Basic information
Public title
Therapeutic effect of Intravesical Bacillus Calmette-Guerin(IMMUCYST) to nonmuscle-invasive urothelial carcinoma of bladder and examination of safety
Acronym
Therapeutic effect of Intravesical Bacillus Calmette-Guerin to nonmuscle-invasive urothelial carcinoma of bladder and examination of safety
Scientific Title
Therapeutic effect of Intravesical Bacillus Calmette-Guerin(IMMUCYST) to nonmuscle-invasive urothelial carcinoma of bladder and examination of safety
Scientific Title:Acronym
Therapeutic effect of Intravesical Bacillus Calmette-Guerin to nonmuscle-invasive urothelial carcinoma of bladder and examination of safety
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The therapeutic effect and the safety of Intravesical Bacillus Calmette-Guerin(BCG) are examined for nonmuscle-invasive urothelial carcinoma of bladder.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
recurrence free survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
tretment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CIS or high grade T1 bladder cancer
Key exclusion criteria
allergy for BCG
pregnancy
tuberculosis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Fujisawa |
Organization
University of Kobe,Graduate school of medicine
Division name
Department of Urology
Zip code
Address
7-5-1,Kusunoki-cho, Tyuo-ku, Kobe-city
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Kobe,Graduate school of medicine
Division name
Department of Urology
Zip code
Address
7-5-1,Kusunoki-cho, Tyuo-ku, Kobe-city
TEL
Homepage URL
Sponsor or person
Institute
University of Kobe,Graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
not selected
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
| 2010 | Year | 12 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2010 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 07 | Day |
Last modified on
| 2012 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005565
