UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040457 |
|---|---|
| Receipt number | 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 08:57:28 |
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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
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
ya_su_koba@yahoo.co.jp
Sponsor or person
Institute
Kinki Central Hospital of Mutual Aid Association of Public School Teachers
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046176
