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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000040457
Receipt No. R000046176
Scientific Title Influences of intravesical BCG therapy in lower urinary tract symptom
Date of disclosure of the study information 2020/05/20
Last modified on 2020/06/17

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Basic information
Public title Influences of intravesical BCG therapy in lower urinary tract symptom
Acronym Influences of intravesical BCG therapy
Scientific Title Influences of intravesical BCG therapy in lower urinary tract symptom
Scientific Title:Acronym Influences of intravesical BCG therapy
Region
Japan

Condition
Condition Urothelial carcinoma in situ of the bladder
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the influences of intravesical BCG therapy in lower urinary tract symptom
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Influences of intravesical BCG therapy on local symptoms

Before intravesical injection of BCG
2 weeks, 3 months, 6 months after intravesical BCG therapy
Key secondary outcomes Influences of on systemic symptoms
Discontinuation rate of intravesical BCG therapy and its reason
Recurrence after intravesical BCG therapy

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 Patients who receive intravesical BCG therapy for urothelial carcinoma in situ of the bladder
Key exclusion criteria Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Yasuyuki
Middle name
Last name Kobayashi
Organization Kinki Central Hospital of Mutual Aid Association of Public School Teachers
Division name Department of Urology
Zip code 664-8533
Address 3-1 Kurumazuka, Itami, Hyogo
TEL 072-781-3712
Email ya_su_koba@yahoo.co.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Kobayashi
Organization Kinki Central Hospital of Mutual Aid Association of Public School Teachers
Division name Department of Urology
Zip code 664-8533
Address 3-1 Kurumazuka, Itami, Hyogo
TEL 072-781-3712
Homepage URL
Email ya_su_koba@yahoo.co.jp

Sponsor
Institute Kinki Central Hospital of Mutual Aid Association of Public School Teachers
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kinki Central Hospital of Mutual Aid Association of Public School Teachers
Address 3-1 Kurumazuka, Itami, Hyogo
Tel 072-781-3712
Email ya_su_koba@yahoo.co.jp

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 公立学校共済組合近畿中央病院

Other administrative information
Date of disclosure of the study information
2020 Year 05 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 Terminated
Date of protocol fixation
2020 Year 04 Month 30 Day
Date of IRB
2020 Year 04 Month 30 Day
Anticipated trial start date
2020 Year 05 Month 20 Day
Last follow-up date
2025 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2020 Year 05 Month 20 Day
Last modified on
2020 Year 06 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046176

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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