UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038906 |
|---|---|
| Receipt number | R000040655 |
| Scientific Title | Photodynamic diagnosis involving extracorporeal treatment with hexaminolevulinate for bladder cancer cells in surveillance of non muscle invasive bladder cancer |
| Date of disclosure of the study information | 2019/12/16 |
| Last modified on | 2022/06/23 11:44:44 |
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Basic information
Public title
Photodynamic diagnosis involving extracorporeal treatment with hexaminolevulinate for bladder cancer cells in surveillance of non muscle invasive bladder cancer
Acronym
Photodynamic diagnosis using hexaminolevulinate in surveillance of non-muscle invasive bladder cancer
Scientific Title
Photodynamic diagnosis involving extracorporeal treatment with hexaminolevulinate for bladder cancer cells in surveillance of non muscle invasive bladder cancer
Scientific Title:Acronym
Photodynamic diagnosis using hexaminolevulinate in surveillance of non-muscle invasive bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comparison with the findings on cystoscopy and the results of photodynamic diagnosis using hexaminolevulinate
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison with the findings on cystoscopy and the results of photodynamic diagnosis using hexaminolevulinate every three months after transurethral resection of bladder cancer
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
1 patients with non muscle invasive bladder cancer confirmed by transurethral resection
2 patients aged 20 and over
3 patients who plan to commute Nara Medical University for follow-up.
Key exclusion criteria
1 patients who received cystectomy
2 patients without informed consent
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Nakai |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8521
Address
Shijyocho 840
TEL
0744223051
nakaiyasusiuro@live.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Nakai |
Organization
Nara Medical University
Division name
Department of Urology
Zip code
634-8521
Address
Shijyocho 840
TEL
0744223051
Homepage URL
nakaiyasusiuro@live.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
the ethics committee of Nara Medical university
Address
Shijyocho 840, Kashihara, Nara
Tel
0744223051
nakaiyasusiuro@live.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 16 | 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
162
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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2019 | Year | 12 | Month | 16 | Day |
Last modified on
| 2022 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040655
