UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006362 |
|---|---|
| Receipt number | R000007533 |
| Scientific Title | Maintenance therapy with bacillus Calmette-Guérin Connaught stain for non-muscle invasive bladder cancer after transurethral resection: prospective study with low-dose instillation. |
| Date of disclosure of the study information | 2011/09/16 |
| Last modified on | 2014/03/16 18:05:31 |
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Basic information
Public title
Maintenance therapy with bacillus Calmette-Guérin Connaught stain for non-muscle invasive bladder cancer after transurethral resection: prospective study with low-dose instillation.
Acronym
Maintenance therapy with bacillus Calmette-Guérin Connaught stain for non-muscle invasive bladder cancer after transurethral resection: prospective study with low-dose instillation.
Scientific Title
Maintenance therapy with bacillus Calmette-Guérin Connaught stain for non-muscle invasive bladder cancer after transurethral resection: prospective study with low-dose instillation.
Scientific Title:Acronym
Maintenance therapy with bacillus Calmette-Guérin Connaught stain for non-muscle invasive bladder cancer after transurethral resection: prospective study with low-dose instillation.
Region
| Japan |
Condition
Condition
Non muscle-invasive bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the recurrence-preventing efficacy and safety of BCG maintenance therapy with low-dose instillation (BCG 40mg) for non-muscle invasive bladder cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Incidence rate of adverse events
2. Rate of Patients who accomplish the protocol of this study
Key secondary outcomes
Recurrence- and progression-rate during 2-year after the final instillation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Diagnosed NMIBC by histopathological study.
2 Number of tumors is more than three, more than three times recurrences or recurrence within 1 year
3 Patients who accept this study
Key exclusion criteria
1 Patients who have current or previous upper tract tumor.
2 Patients whose bladder volume is less than 100 ml, which is mesured by uktrasonography.
3 Patients who suffered with urinary frequency (OAB symptom score<=6)
4 Patients who received BCG theraphy previously.
5 Patients who have contraindication of BCG.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideyasu Matsuyama |
Organization
Graduate school of Medicine, Yamaguchi University
Division name
Dpt. Urology
Zip code
Address
Minamikogushi 1-1-1, Ube, Yamaguchi, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate school of Medicine, Yamaguchi University
Division name
Dpt. Urology
Zip code
Address
TEL
0836-22-2275
Homepage URL
takahara@yamaguchi-u.ac.jp
Sponsor or person
Institute
Graguate school of Medicine, Yamaguchi University
Institute
Department
Personal name
Funding Source
Organization
Graguate school of Medicine, Yamaguchi University
Organization
Division
Category of Funding Organization
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
| 2011 | Year | 09 | Month | 16 | 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
| 2011 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2014 | Year | 03 | Month | 16 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2011 | Year | 09 | Month | 16 | Day |
Last modified on
| 2014 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007533
