UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047198 |
|---|---|
| Receipt number | R000053290 |
| Scientific Title | Development of biomarker predicting the response of immunotherapy for patients with urothelial cancer using urine miRNA |
| Date of disclosure of the study information | 2022/03/18 |
| Last modified on | 2022/03/17 15:04:07 |
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Basic information
Public title
Development of biomarker predicting the response of immunotherapy for patients with urothelial cancer using urine miRNA
Acronym
Development of precision medicine for patients with urothelial cancer
Scientific Title
Development of biomarker predicting the response of immunotherapy for patients with urothelial cancer using urine miRNA
Scientific Title:Acronym
Development of precision medicine for patients with urothelial cancer
Region
| Japan |
Condition
Condition
urothelial cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Regarding the immunotherapy for urothelial carcinoma, the efficacy rate is very low (20-30%), but there has been no biomarker to predict the response so far. This has been pointed out as the major problem due to the high cost and the specific side effect of the immunotherapy. Thus, if we have the biomarker which can extract the patient with good response or poor response for the immunotherapy, then we can avoid the unnecessary treatment for patient with poor response. The purpose of this study is to examine and explore the profiling of the urine miRNA for the patients with urothelial carcinoma.
Basic objectives2
Others
Basic objectives -Others
explore the difference of urine miRNAs between patients with good response and poor response of the immunotherapy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The difference of the urine miRNAs between patients with good and poor response for immunotherapy will be analyzed for patients with urothelial cancer before immunotherapy.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Male or female patients 20 years of age or older on the date of the consent
2.Documented histological or radiological diagnosis of urothelial carcinoma without metastasis and without patients after radical cystectomy
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
1, patients with history of using immunotherapy for urothelial or non-urothelial carcinoma before the registration of this study.
2, patients with other cancer
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yosuke |
| Middle name | |
| Last name | Hirasawa |
Organization
Tokyo Medical University
Division name
Department of Urology
Zip code
1600023
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
0333426111
wbqmd473@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yosuke |
| Middle name | |
| Last name | Hirasawa |
Organization
Tokyo Medical University
Division name
Department of Urology
Zip code
1600023
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
0333426111
Homepage URL
wbqmd473@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI, JSPS
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioehics Committee, Tokyo Medical University
Address
6-7-1 Nishi-Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel
0333426111
kenkyu-s@tokyo-med.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
| 2022 | Year | 03 | Month | 18 | 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
| 2022 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 04 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The result of this study will be reported in meeting or papers.
Management information
Registered date
| 2022 | Year | 03 | Month | 17 | Day |
Last modified on
| 2022 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053290
