UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009347 |
|---|---|
| Receipt number | R000010979 |
| Scientific Title | A prospective comparative study of intravesical Bacillus Calmette-Guerin (BCG) therapy with the Tokyo or Connaught strains for non-muscle invasive bladder cancer |
| Date of disclosure of the study information | 2012/11/16 |
| Last modified on | 2013/05/19 20:02:15 |
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Basic information
Public title
A prospective comparative study of intravesical Bacillus Calmette-Guerin (BCG) therapy
with the Tokyo or Connaught strains for non-muscle invasive bladder cancer
Acronym
Tokyo and Connaught BCG Strains for Bladder Cancer
Scientific Title
A prospective comparative study of intravesical Bacillus Calmette-Guerin (BCG) therapy
with the Tokyo or Connaught strains for non-muscle invasive bladder cancer
Scientific Title:Acronym
Tokyo and Connaught BCG Strains for Bladder Cancer
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy and adverse events of the Bacillus Calmette Guerin Tokyo 172 and Connaught strains for non-muscle invasive bladder cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy, side effects
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
the BCG Tokyo 172 strain group
Interventions/Control_2
the BCG Connaught strain group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with pathological findings corresponding to stage Ta/T1 or Tis, multiple tumors, and a recurrence-free period of ≤3 months were eligible for intravesical BCG therapy.
Key exclusion criteria
Patients with a history of intravesical therapy or upper urinary tract tumor were excluded
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiji Ogura |
Organization
Japanese Red Cross Otsu Hospital
Division name
Urology
Zip code
Address
1-1-35 Nagara Otsu Shiga Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Japanese Red Cross Otsu Hospital
Division name
Administration
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Keiji Ogura
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
The Department of Urology, Japanese Red Cross Otsu Hospital, Otsu, Shiga, Japan
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 16 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Suspended
Date of protocol fixation
| 2004 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 01 | Month | 15 | 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 | 11 | Month | 16 | Day |
Last modified on
| 2013 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010979
