UMIN-CTR Clinical Trial

Basic information
Public title	Research to find new indicators for diagnosis and treatment of bladder cancer using exosomes in urine
Acronym	Diagnosis and treatment of bladder cancer
Scientific Title	Identification of novel biomarkers for diagnosis and treatment of bladder cancer using urinary exosomes
Scientific Title:Acronym	Diagnosis and treatment of bladder cancer
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to examine whether bladder cancer-specific exosomes in urine are useful as diagnostic and prognostic markers for bladder cancer and to explore how they are involved in the growth and progression of bladder cancer. Next, we will discover miRNAs that inhibit the secretion of exosomes specific to bladder cancer, i.e., miRNAs that inhibit the secretion of exosomes by cancer cells, analyze their effects on the function of bladder cancer, and develop a novel intravesical injection therapy using these miRNAs.
Basic objectives2	Others
Basic objectives -Others	diagnosis
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Exosomes extracted from urine samples will be analyzed using the ExoScreen method to evaluate the difference in expression of specific exosomes between bladder cancer patients and non-cancer patients.
Key secondary outcomes	In immunohistochemical staining using surgical specimens, the expression of target substances in cancer tissues, mainly nucleic acids and proteins including miRNAs, will be compared with the expression in non-cancerous tissues.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	1) Urine specimen In patients with bladder cancer, urine should be collected at the time of diagnosis, when postoperative recurrence is confirmed, before and after surgery during hospitalization for cancer resection, and before and after chemotherapy, in addition to the 3-6 month frequency during outpatient visits. There is no guideline for the timing of urine collection except for patients with bladder cancer, and urine should be collected only once after consent. 2) Surgical specimens Of the histopathological specimens of bladder tumors obtained by transurethral resection of bladder tumor or total cystectomy, the remaining surplus specimens used for diagnosis are used.
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 who are able to collect urine 1) Patients with bladder cancer: diagnosed by various imaging tests, urine cytology, and cystoscopy 2) Patients with benign diseases not accompanied by infection: benign prostatic hyperplasia, ureteral stones, etc. 3) Normal patients: Patients with no obvious organic urological disease such as kidney transplant donors 4) Patients with urinary tract infection: pyelonephritis, cystitis, prostatitis 5) Patients with urological cancer other than bladder cancer: prostate cancer, testicular cancer, renal cell carcinoma
Key exclusion criteria	1) Patients undergoing treatment for malignant diseases in other departments 2) Patients who are judged by the principal investigator to be unsuitable as subjects. 3) Patients who have expressed their intention not to cooperate in this study.
Target sample size	420

Research contact person
Name of lead principal investigator	1st name Nozomi Middle name Last name Hayakawa
Organization	St.Marianna University School of Medicine
Division name	Department of Urology
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL	+81-44-977-8111
Email	nozomi.hayakawa@marianna-u.ac.jp

Public contact
Name of contact person	1st name Wataru Middle name Last name Usuba
Organization	St.Marianna University School of Medicine
Division name	Department of Urology
Zip code	216-8511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
TEL	+81-44-977-8111
Homepage URL	https://www.marianna-u.ac.jp/hospital/
Email	w2usuba@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Bioethics Committee, St. Marianna University School of Medicine
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki, 216-8511, Japan
Tel	+81-44-977-8111
Email	k-sienbu.mail@marianna-u.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	2021 Year 10 Month 12 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	Open public recruiting
Date of protocol fixation	2021 Year 10 Month 01 Day
Date of IRB	2021 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 10 Month 25 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 12 Day
Last modified on	2022 Year 10 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000052099