UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017714 |
|---|---|
| Receipt number | R000020521 |
| Scientific Title | Transurethral resection of bladder tumor using probe-based confocal laser endomicroscopy |
| Date of disclosure of the study information | 2015/06/01 |
| Last modified on | 2015/05/28 10:11:46 |
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Basic information
Public title
Transurethral resection of bladder tumor using probe-based confocal laser endomicroscopy
Acronym
TURBT using CLE
Scientific Title
Transurethral resection of bladder tumor using probe-based confocal laser endomicroscopy
Scientific Title:Acronym
TURBT using CLE
Region
| Japan |
Condition
Condition
Bladder Cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Detection of bladder cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection rate of bladder tumor
Key secondary outcomes
Disease free survival, safety
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Confocal laser endomicroscopy
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
Patient with bladder cancer
over 20 years old
PS 0-1
Key exclusion criteria
Allergy of fluorescein
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshio Naya |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
465 Kajiicho, Kamigyo-ku, Kyoto
TEL
075-251-5595
ynaya@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshio Naya |
Organization
Kyoto Prefectural University of Medicine
Division name
Urology
Zip code
Address
465 Kajiicho, Kamigyo-ku, Kyoto
TEL
075-251-5595
Homepage URL
ynaya@koto.kepu-m.ac.jp
Sponsor or person
Institute
Department of Urology, Kyoto Prefectural University of Mediicine
Institute
Department
Personal name
Funding Source
Organization
Department of Urology, Kyoto Prefectural University of Mediicine
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
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
| 2015 | Year | 06 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
Management information
Registered date
| 2015 | Year | 05 | Month | 28 | Day |
Last modified on
| 2015 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020521
