UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008176 |
|---|---|
| Receipt number | R000002279 |
| Scientific Title | Placebo controlled, randomized trial, comparing the efficacy of white light cystoscopy with the fluorescence cystoscopy with the use of hexaminolevulinate, regarding the diagnosis and treatment of bladder cancer |
| Date of disclosure of the study information | 2012/06/15 |
| Last modified on | 2012/06/15 00:26:59 |
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Basic information
Public title
Placebo controlled, randomized trial, comparing the efficacy of white light cystoscopy with the fluorescence cystoscopy with the use of hexaminolevulinate, regarding the diagnosis and treatment of bladder cancer
Acronym
Fluorescence cystoscopy with hexaminolevulinate
Scientific Title
Placebo controlled, randomized trial, comparing the efficacy of white light cystoscopy with the fluorescence cystoscopy with the use of hexaminolevulinate, regarding the diagnosis and treatment of bladder cancer
Scientific Title:Acronym
Fluorescence cystoscopy with hexaminolevulinate
Region
| Europe |
Condition
Condition
Bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prove if this method really helps to improve the transurethral resection of bladder cancer in clinical practice and if this effects to a better overall outcome of the disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To estimate the sensitivity and specificity of the method
To indentify, other than cancer, lesions of urothelium giving positive fluorescence
To indentify the degree and how this method changes the way of transurethral resection of bladder cancer in every day clinical practice
To prove if this method changes the overall treatment of patients
To prove if this method helps the surgeon to improve his transurethral resection outcome
To find out if it reduces the recurrence rate of the disease
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
transurethral resection of bladder cancer with the use of hexaminolevulinate
Interventions/Control_2
transurethral resection of bladder cancer
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
| 18 | years-old | < |
Age-upper limit
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
suspected or existing superficial bladder cancer
Key exclusion criteria
haematuria, porfyria
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Pavlos Gkritsios |
Organization
"Papageorgiou Hospital" of Thessaloniki
Division name
Urology
Zip code
Address
N Eykarpia - Ring road
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
"Papageorgiou Hospital" of Thessaloniki
Division name
Urology clinic
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
"Papageorgiou Hospital" of Thessaloniki
Institute
Department
Personal name
Funding Source
Organization
"Papageorgiou Hospital" of Thessaloniki
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2012 | Year | 06 | Month | 15 | 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
Completed
Date of protocol fixation
| 2007 | Year | 12 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | 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
| 2012 | Year | 06 | Month | 15 | Day |
Last modified on
| 2012 | Year | 06 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
