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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000030054
Receipt No. R000034029
Scientific Title Development of urothelial cancer-Specific mRNA and miRNA Assay in Human Urinary Exosomes and Microvesicles
Date of disclosure of the study information 2017/11/20
Last modified on 2017/11/20

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Basic information
Public title Development of urothelial cancer-Specific mRNA and miRNA Assay in Human Urinary Exosomes
and Microvesicles
Acronym Development of urothelial cancer-Specific mRNA and miRNA Assay in Human Urinary Exosomes
and Microvesicles
Scientific Title Development of urothelial cancer-Specific mRNA and miRNA Assay in Human Urinary Exosomes
and Microvesicles
Scientific Title:Acronym Development of urothelial cancer-Specific mRNA and miRNA Assay in Human Urinary Exosomes
and Microvesicles
Region
Japan

Condition
Condition Bladder Cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Urinary exosomes and microvesicles (EMV) have been investigated extensively as promising biomarkers in the recent years. We extracted extracellular vesicles from urine of urothelial carcinoma patients and the control group to try to find cancer-specific microRNAs in urinary extracellular vesicles as new biomarkers.
Basic objectives2 Others
Basic objectives -Others In this study, we extracted exosomes from the urine of patients with urothelial Carcinoma and the control, and focused on the mRNA miRNA overexpressed in urinary exosome in urotherial carcinoma patients compared to the control to identify cancer specific mRNA and miRNA in urinary exosome for possible use as new biomarkers.
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Primary
The analysis of the expression of mRNA and miRNA in urine exosome.
Secondary
The analysis of the association between the expression of the specific marker and the clinical data.
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 1.Male or female patients 20 years of age or older on the day of consent

2.Documented histological or radiological diagnosis of bladder cancer or upper urinary tract cancer without metastasis

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 The patients who are regarded as inappropriate for entering this study by principal investigator
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuo Shinohara
Organization Hokkaido University Graduate School of Medicine
Division name Department of Renal and Genitourinary surgery
Zip code
Address North15 West7, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-706-5966
Email nozomis@mbj.nifty.com

Public contact
Name of contact person
1st name
Middle name
Last name Takahiro Osawa
Organization Hokkaido University Hospital
Division name Department of Renal and Genitourinary surgery
Zip code
Address North14 West5, Kita-ku, Sapporo, Hokkaido, Japan
TEL 011-716-1161
Homepage URL
Email taka0573@gmail.com

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2017 Year 11 Month 20 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
2017 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information none

Management information
Registered date
2017 Year 11 Month 20 Day
Last modified on
2017 Year 11 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034029

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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