UMIN-CTR Clinical Trial

Basic information
Public title	Development of biomarker predicting the response of immunotherapy for patients with urothelial cancer using urine miRNA
Acronym	Development of precision medicine for patients with urothelial cancer
Scientific Title	Development of biomarker predicting the response of immunotherapy for patients with urothelial cancer using urine miRNA
Scientific Title:Acronym	Development of precision medicine for patients with urothelial cancer
Region	Japan

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

Objectives
Narrative objectives1	Regarding the immunotherapy for urothelial carcinoma, the efficacy rate is very low (20-30%), but there has been no biomarker to predict the response so far. This has been pointed out as the major problem due to the high cost and the specific side effect of the immunotherapy. Thus, if we have the biomarker which can extract the patient with good response or poor response for the immunotherapy, then we can avoid the unnecessary treatment for patient with poor response. The purpose of this study is to examine and explore the profiling of the urine miRNA for the patients with urothelial carcinoma.
Basic objectives2	Others
Basic objectives -Others	explore the difference of urine miRNAs between patients with good response and poor response of the immunotherapy.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The difference of the urine miRNAs between patients with good and poor response for immunotherapy will be analyzed for patients with urothelial cancer before immunotherapy.
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.Male or female patients 20 years of age or older on the date of the consent 2.Documented histological or radiological diagnosis of urothelial carcinoma without metastasis and without patients after radical cystectomy 3.Voluntary written consent must be given after sufficient explanation with the understanding what this study is and that consent may be withdrawn by the patient at any time without prejudice to future medical care
Key exclusion criteria	1, patients with history of using immunotherapy for urothelial or non-urothelial carcinoma before the registration of this study. 2, patients with other cancer
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Yosuke Middle name Last name Hirasawa
Organization	Tokyo Medical University
Division name	Department of Urology
Zip code	1600023
Address	6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL	0333426111
Email	wbqmd473@yahoo.co.jp

Public contact
Name of contact person	1st name Yosuke Middle name Last name Hirasawa
Organization	Tokyo Medical University
Division name	Department of Urology
Zip code	1600023
Address	6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL	0333426111
Homepage URL
Email	wbqmd473@yahoo.co.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	KAKENHI, JSPS
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	JAPAN

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

IRB Contact (For public release)
Organization	Bioehics Committee, Tokyo Medical University
Address	6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel	0333426111
Email	kenkyu-s@tokyo-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	2022 Year 03 Month 18 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	2022 Year 03 Month 04 Day
Date of IRB	2022 Year 03 Month 04 Day
Anticipated trial start date	2022 Year 03 Month 18 Day
Last follow-up date	2028 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The result of this study will be reported in meeting or papers.

Management information
Registered date	2022 Year 03 Month 17 Day
Last modified on	2022 Year 03 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053290