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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006362
Receipt No. 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

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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
Email

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
Email takahara@yamaguchi-u.ac.jp

Sponsor
Institute Graguate school of Medicine, Yamaguchi University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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