UMIN-CTR Clinical Trial

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