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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041202
Receipt No. R000047050
Scientific Title Changes in microRNA expressions before and after urological cancer treatment
Date of disclosure of the study information 2020/10/01
Last modified on 2020/07/24

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Basic information
Public title Changes in microRNA expressions before and after urological cancer treatment
Acronym MicroRNA trial in urological cancer
Scientific Title Changes in microRNA expressions before and after urological cancer treatment
Scientific Title:Acronym MicroRNA trial in urological cancer
Region
Japan

Condition
Condition Prostate cancer, renal cancer, urothelial cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Elucidation of miRNA expression patterns before and after treatment for urological cancer
Basic objectives2 Others
Basic objectives -Others Elucidation of specific miRNA expression patterns in urological cancer
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in miRNA expression patterns before and after urological cancer treatment
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
40 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who will undergo surgical treatment for prostate cancer
patients that will undergo surgical treatment or drug treatment for kidney cancer
Patients that will undergo surgical treatment or drug treatment for urothelial cancer (bladder cancer, renal ureteral cancer)
Key exclusion criteria Patients with prostate cancer who have metastasis
Patients who have undergone Neoadjuvant drug therapy for the target disease
Patients who are known to have multiple cancers (excluding cases that have been treated with other cancers and have not recurred for 5 years or more)
Patients who are judged to be unsuitable for participation in this study by the principal investigator/research coordinator
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Yoshihisa
Middle name
Last name Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Urology
Zip code 466-8550
Address 65 Tsurumai, Showa-ku, Nagoya, JAPAN
TEL 052-744-2985
Email yoshi44@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Yoshihisa
Middle name
Last name Matsukawa
Organization Nagoya University Graduate School of Medicine
Division name Urology
Zip code 466-8550
Address 65 Tsurumai, Showa-ku, Nagoya, JAPAN
TEL 052-744-2985
Homepage URL
Email yoshi44@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
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 Nagoya University Graduate School of Medicine's ethics committee
Address 65 Tsurumai, Showa-ku, Nagoya, JAPAN
Tel 052-744-2061
Email ethics(at)med.nagoya-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
2020 Year 10 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
2020 Year 08 Month 31 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2023 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
2020 Year 07 Month 24 Day
Last modified on
2020 Year 07 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047050

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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