UMIN-CTR Clinical Trial

Basic information
Public title	The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer
Acronym	The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer
Scientific Title	The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer
Scientific Title:Acronym	The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer
Region	Japan

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

Objectives
Narrative objectives1	The search for urinary biomarkers for bladder cancer by comparing between tumor immune microenvironment, immune environment in urine, peripheral blood, and clinical data.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Survival
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with bladder cancer who undergo transurethral resection of bladder tumor in Tokyo Medical and Dental University
Key exclusion criteria	1.Patients with human immunodeficiency virus or acquired immunodeficiency syndrome and related disorders 2.Patients with hepatitis B surface antigen 3.Patients with hepatitis C virus antibody 4.Patients undergoing steroid therapy 5.Patients during pregnancy and lactation
Target sample size	220

Research contact person
Name of lead principal investigator	1st name Yasuhisa Middle name Last name Fujii
Organization	Tokyo Medical and Dental University
Division name	Division of urology
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan
TEL	03-3813-6111
Email	y-fujii.uro@tmd.ac.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Nakayama
Organization	Tokyo Medical and Dental University
Division name	Division of urology
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL	03-3813-6111
Homepage URL
Email	nakayama.uro@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	self-sustaining
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Ethics Review Board of Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel	03-3813-6111
Email	info.bec@tmd.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	2018 Year 04 Month 01 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 03 Month 01 Day
Date of IRB	2018 Year 02 Month 27 Day
Anticipated trial start date	2018 Year 04 Month 01 Day
Last follow-up date	2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Research for immune environment for patients with bladder cancer

Management information
Registered date	2018 Year 01 Month 20 Day
Last modified on	2019 Year 07 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035290