UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of diagnostic test and curative effect for the superficial bladder cancer based oral 5-aminolevulinic acid (5-ALA) prior to transurethral resection (TUR)
Title of the study (Brief title)	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	Hironori Betsunoh
Organization	Dokkyo Medical University
Division name	Urology
Address	880Kitakobayashi Mibu, Shimotsuga Tochigi 321-0293 JAPAN
TEL	0282872162
Email	hirobets@dokkyomed.ac.jp

Public contact
Name of contact person	Hironori Betsunoh
Organization	Dokkyo Medical University
Division name	Urology
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 11 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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