UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041202 |
|---|---|
| Receipt number | 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 11:40:51 |
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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
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
yoshi44@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047050
