UMIN-CTR Clinical Trial

Basic information
Public title	Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in Non-muscle invasive bladder cancer
Acronym	Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in Non-muscle invasive bladder cancer
Scientific Title	Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in Non-muscle invasive bladder cancer
Scientific Title:Acronym	Investigation for intravesical recurrences between with and without BCG therapies according to history of therapeutic agents for dysuria in Non-muscle invasive bladder cancer
Region	Japan

Condition
Condition	Non-muscle invasive bladder cancer
Classification by specialty	Urology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study is to investigate the status of therapeutic agents for dysuria and recurrence in Non-muscle invasive bladder cancer (NMIBC) two groups between non-BCG therapy and BCG therapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence
Key secondary outcomes

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	20 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	1) Age: 20 years or older, regardless of gender. 2) Urothelial carcinoma who became T1 or less by TUR-BT 3) ECOG PS 0 or 1 4) Expected to survive for more than 2 years 5) Patients who have given written informed consent prior to enrollment in this study 6) Patients who have not received other treatments for bladder cancer (immunotherapy, chemotherapy, molecular targeted therapy, investigational drugs) 7) Cases without serious organ complications in heart, lung, liver, kidney, etc.
Key exclusion criteria	1) HIV infection or active chronic hepatitis 2) Active infection (grade 3 or higher according to CTCAE Version 4.0) 3) The cases judged by doctors to be inappropriate.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Wataru Middle name Last name Obara
Organization	Iwate Medical University
Division name	Urology
Zip code	028-3695
Address	2-1-1 Idai-dori Yhaba Shiwa, Iwate
TEL	+81196137111
Email	ikyoku@urology-imu.jp

Public contact
Name of contact person	1st name Yoichiro Middle name Last name Kato
Organization	Iwate Medical University
Division name	Urology
Zip code	028-3695
Address	2-1-1 Idai-dori Yhaba Shiwa, Iwate
TEL	019-613-7111
Homepage URL
Email	ikyoku@urology-imu.jp

Sponsor
Institute	Iwate Medical University
Institute
Department

Funding Source
Organization	Iwate Medical University
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	Iwate Medical University
Address	2-1-1 Idai-dori Yhaba Shiwa, Iwate
Tel	+81196137111
Email	katoyooo@iwate-med.ac.jp

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	2020 Year 09 Month 30 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	Enrolling by invitation
Date of protocol fixation	2020 Year 01 Month 02 Day
Date of IRB	2020 Year 02 Month 28 Day
Anticipated trial start date	2020 Year 01 Month 02 Day
Last follow-up date	2020 Year 04 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No paticularity

Management information
Registered date	2020 Year 01 Month 02 Day
Last modified on	2020 Year 01 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044523