UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001321 |
|---|---|
| Receipt number | R000001600 |
| Scientific Title | The study of Immucyst for the prophylaxis of the superficial bladder cancer at a intermediate risk for the intravesical recurrence |
| Date of disclosure of the study information | 2008/08/20 |
| Last modified on | 2010/05/05 02:29:36 |
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Basic information
Public title
The study of Immucyst for the prophylaxis of the superficial bladder cancer at a intermediate risk for the intravesical recurrence
Acronym
IMAX
Scientific Title
The study of Immucyst for the prophylaxis of the superficial bladder cancer at a intermediate risk for the intravesical recurrence
Scientific Title:Acronym
IMAX
Region
| Japan |
Condition
Condition
superficial bladder cancer at the intermediate risk
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the effectiveness and safety of Immucyst for the prophylaxis of intravesical recurrence after TUR-BT to the superficial bladder cancer at the intermediate risk
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intravasecal recurrence
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravesical instillation of Immucsyt
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) the tumors of Ta or T1 which was completely resected with TUR-BT
2) No history of BCG instillation therapy
3) No major organs dysfunction and no problems for BCG instillation therapy
Key exclusion criteria
1) The history or the presence of Invasive bladder cancer with T2 or more
2) untreated CIS
3) single tumor of Ta, G1
4) tumor of T1,G3
5) associated malignant tumors at the upper urinary tract and/or the urethra
6) the presence of metastases to the lymph nodes and/or the distant organ or active double cancer
7) The presence of active tuberculosis infection with or without the anti-tuberculosis therapy
8) Contraindication for BCG instillation therapy
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Tanabe |
Organization
Tokyo Women's Medical University
Division name
Department of Urology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsunenori Kondo |
Organization
Tokyo Women's Medical University
Division name
Department of Urology
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo
TEL
03-3353-8111
Homepage URL
https://www.statz.jp/iMMuCyst200803/Main_Menu.php
tkondo@kc.twmu.ac.jp
Sponsor or person
Institute
Department of Urology, Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Nippon Kayaku
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
1009
Org. issuing International ID_1
Tokyo Women's Medical University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 08 | Month | 20 | 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
| 2006 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 19 | Day |
Last modified on
| 2010 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001600
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
