UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030054 |
|---|---|
| Receipt number | 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 | 2025/01/06 11:13:33 |
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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
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
taka0573@gmail.com
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
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
Completed
Date of protocol fixation
| 2017 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 25 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
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
| 2025 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034029
