UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000001321
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email tkondo@kc.twmu.ac.jp

Sponsor
Institute Department of Urology, Tokyo Women's Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.