UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046337 |
|---|---|
| Receipt number | R000052873 |
| Scientific Title | Examination of disinfection method for urine after BCG intravesical infusion therapy |
| Date of disclosure of the study information | 2022/01/01 |
| Last modified on | 2022/11/21 10:45:38 |
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Basic information
Public title
Examination of disinfection method for urine after BCG intravesical infusion therapy
Acronym
Examination of disinfection method for urine after BCG intravesical infusion therapy
Scientific Title
Examination of disinfection method for urine after BCG intravesical infusion therapy
Scientific Title:Acronym
Examination of disinfection method for urine after BCG intravesical infusion therapy
Region
| Japan |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Disinfect BCG-containing urine with Etaprocol, and examine whether it is more effective and safer than disinfection with sodium hypochlorite.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of the temperature rise that occurs when each disinfectant solution is added to BCG-containing urine and mixed together
Key secondary outcomes
Evaluation of the concentration of gas generated when each disinfectant solution is added and mixed with BCG-containing urine, the disinfecting effect of each disinfectant on Mycobacterium tuberculosis, and the sensory degree of the odor generated at that time.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Disinfect BCG-containing urine with Etaprocol, and examine whether it is more effective and safer than disinfection with sodium hypochlorite.
Interventions/Control_2
Disinfect BCG-containing urine with Etaprocol, and examine whether it is more effective and safer than disinfection with sodium hypochlorite.
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
Patients diagnosed with non-muscle invasive bladder cancer and required BCG intravesical instillation therapy
Key exclusion criteria
Patients who are contraindicated for BCG intravesical instillation therapy
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kameda |
Organization
Haga red cross hospital
Division name
Urology
Zip code
321-4308
Address
271 Nakago, Moka, Tochigi
TEL
0285-82-2195
kamedadesu1002@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kameda |
Organization
Haga red cross hospital
Division name
Urology
Zip code
321-4308
Address
271 Nakago, Moka, Tochigi
TEL
0285-82-2195
Homepage URL
kamedadesu1002@yahoo.co.jp
Sponsor or person
Institute
Haga red cross hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Sapporo Medical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Haga red cross hospital
Address
271 Nakago, Moka, Tochigi 321-4308
Tel
0285-82-2195
kamedadesu1002@yahoo.co.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
R3_15
Org. issuing International ID_1
Haga Red Cross Hospital Ethics Review Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 01 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 11 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2022 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052873
