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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008176
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute "Papageorgiou Hospital" of Thessaloniki
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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