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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035009
Receipt No. R000039918
Scientific Title Evaluation of diagnostic test and curative effect for the superficial bladder cancer based oral 5-aminolevulinic acid (5-ALA) prior to transurethral resection (TUR)
Date of disclosure of the study information 2018/11/26
Last modified on 2018/11/26

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Basic information
Public title Evaluation of diagnostic test and curative effect for the superficial bladder cancer based oral 5-aminolevulinic acid (5-ALA) prior to transurethral resection (TUR)
Acronym The significance of oral 5-aminolevulinic acid (5-ALA) for superficial bladder cancer
Scientific Title Evaluation of diagnostic test and curative effect for the superficial bladder cancer based oral 5-aminolevulinic acid (5-ALA) prior to transurethral resection (TUR)
Scientific Title:Acronym The significance of oral 5-aminolevulinic acid (5-ALA) for superficial bladder cancer
Region
Japan

Condition
Condition superficial bladder cancer
Classification by specialty
Urology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To perform comparative examination for the detection lesions by fluorescent light (FL) between cancerous lesion s and non cancerous lesions
Basic objectives2 Others
Basic objectives -Others To confirm the recurrence rate of superficial bladder cancer using oral 5-ALA prior to TUR
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes We study to confirm the superficial bladder cancer by parts of bladder with oral 5-ALA(20mg/kg) prior to TUR
Key secondary outcomes To evaluate the recurrence rate by parts of bladder with oral(20mg/kg) 5-ALA prior to TUR at 3, 6, 9 and 12 months later from TUR

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria superficial cancer
Key exclusion criteria progressive cancer
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironori Betsunoh
Organization Dokkyo Medical University
Division name Urology
Zip code
Address 880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN
TEL 0282872162
Email hirobets@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Betsunoh
Organization Dokkyo Medical University
Division name Urology
Zip code
Address 880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN
TEL 0282872162
Homepage URL
Email hirobets@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University, Department of Urology
Institute
Department

Funding Source
Organization Dokkyo Medical University, Department of Urology
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
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 獨協医科大学

Other administrative information
Date of disclosure of the study information
2018 Year 11 Month 26 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
2018 Year 11 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To confirm the detection lesion as cancer by fluorescent light. To follow the recurrence or not after TUR.

Management information
Registered date
2018 Year 11 Month 26 Day
Last modified on
2018 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039918

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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