UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001337 |
|---|---|
| Receipt number | R000001625 |
| Scientific Title | Photodynamic diagnosis of bladder cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) |
| Date of disclosure of the study information | 2008/08/27 |
| Last modified on | 2015/04/24 14:38:33 |
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Basic information
Public title
Photodynamic diagnosis of bladder cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)
Acronym
Photodynamic diagnosis of bladder cancer
Scientific Title
Photodynamic diagnosis of bladder cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA)
Scientific Title:Acronym
Photodynamic diagnosis of bladder cancer
Region
| Japan |
Condition
Condition
Superficial bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the value of the photodynamic diagnosis (PDD) of superficial bladder cancer using fluorescence cystoscopy with 5-aminolevulinic acid (5-ALA) and transurethral resection of bladder tumor (TURBT) guided PDD.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Number of side effect by grade
Incidence of side effect by grade
Key secondary outcomes
Diagnostic accuracy: Comparison between fluorescence guide-cystoscopy mediated by 5-ALA and histological findings of collected tissue by biopsy or TURBT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
5-aminolevulinic acid (5-ALA) (unapproved drug by Japanese pharmaceutical affairs law) dissolved in 50mL of 5% glucose solution.
5-ALA solution was administered either way of following:
Orally(1.0g/50mL); 180-240minutes before operation
Instilled intravesically(1.5g/50mL); 90-120 minutes before operation.
For fluorescence excitation a blue light source (D-LIGHT System, Karl Storz Endoscopy Japan K.K.) was used.
Under white and fluorescence light guidance outputted by light source apparatus (D-Light AF System) and videocamera system (Endovision TELECAM SL/IPM-PPD System), tumor locations were recorded, cold cup biopsies were taken and tumors were resected.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patient who has primary and recurrent superficial bladder cancer indicated for transurethral biopsy of bladder mocosa (TU-biopsy) and/or transurethral resection of bladder tumor (TURBT)
Key exclusion criteria
patient who has potential complication of local disorder and systematic absorption of 5-ALA such as solar photosensitivity and liver dysfunction
Target sample size
165
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Shuin |
Organization
Kochi Medical School
Division name
Department of Urology, Kochi Medical School
Zip code
Address
Kohasu, Oko, Nankoku, Kochi, Japan
TEL
088-880-2402
shuint@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiji Inoue |
Organization
Kochi Medical School
Division name
Department of Urology, Kochi Medical School
Zip code
Address
Kohasu, Oko, Nankoku, Kochi, Japan
TEL
088-880-2402
Homepage URL
keiji@kochi-u.ac.jp
Sponsor or person
Institute
Department of Urology, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
-
Other related organizations
Co-sponsor
Ethical committee, Kochi Medical School
Name of secondary funder(s)
Kohasu, Oko, Nankoku, Kochi, Japan
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
| 2008 | Year | 08 | Month | 27 | 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
| 2004 | Year | 02 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 27 | Day |
Last modified on
| 2015 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001625
