UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012398 |
|---|---|
| Receipt number | R000014503 |
| Scientific Title | Detection of Bacillus Galmette-Guerin (Mycobacterium bovis BCG) DNA in Urine Specimens after Intravesical BCG Immunotherapy for Non-muscle Invasive Bladder Cancer. |
| Date of disclosure of the study information | 2013/12/10 |
| Last modified on | 2014/11/26 17:32:30 |
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Basic information
Public title
Detection of Bacillus Galmette-Guerin (Mycobacterium bovis BCG) DNA in Urine Specimens after Intravesical BCG Immunotherapy for Non-muscle Invasive Bladder Cancer.
Acronym
BCG DNA study
Scientific Title
Detection of Bacillus Galmette-Guerin (Mycobacterium bovis BCG) DNA in Urine Specimens after Intravesical BCG Immunotherapy for Non-muscle Invasive Bladder Cancer.
Scientific Title:Acronym
BCG DNA study
Region
| Japan |
Condition
Condition
Non-muscle invasive bladder cancer after BCG intravesical instillation
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy of urine BCG DNA in cancer control
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the presence or absence of urine BCG DNA
The comparison in 5-year disease-specific survival between the presence and absence of urine BCG DNA
Key secondary outcomes
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
NMIBC (cTa or 1N0M0, pTa or 1 N0M0)
after BCG intravesical instillation
Key exclusion criteria
urachal carcinoma
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | SATORU MUTO |
Organization
Teikyo University, School of Medicine
Division name
Department of Urology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211
muto@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | SATORU MUTO |
Organization
Teikyo University, School of Medicine
Division name
Department of Urology
Zip code
Address
2-11-1, Kaga, Itabashi-ku, Tokyo, Japan
TEL
03-3964-1211
Homepage URL
http://teikyo-urology.jp/
muto@med.teikyo-u.ac.jp
Sponsor or person
Institute
Department of Urology, Teikyo University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Teikyo University, School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2013 | Year | 12 | Month | 10 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
prospective observational study
Management information
Registered date
| 2013 | Year | 11 | Month | 25 | Day |
Last modified on
| 2014 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014503
