UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030907 |
|---|---|
| Receipt number | R000035290 |
| Scientific Title | The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer |
| Date of disclosure of the study information | 2018/04/01 |
| Last modified on | 2019/07/23 21:36:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer
Acronym
The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer
Scientific Title
The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer
Scientific Title:Acronym
The search for urinary biomarkers reflecting tumor immune microenvironment for bladder cancer
Region
| Japan |
Condition
Condition
bladder cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The search for urinary biomarkers for bladder cancer by comparing between tumor immune microenvironment, immune environment in urine, peripheral blood, and clinical data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Survival
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
Patients with bladder cancer who undergo transurethral resection of bladder tumor in Tokyo Medical and Dental University
Key exclusion criteria
1.Patients with human immunodeficiency virus or acquired immunodeficiency syndrome and related disorders
2.Patients with hepatitis B surface antigen
3.Patients with hepatitis C virus antibody
4.Patients undergoing steroid therapy
5.Patients during pregnancy and lactation
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Yasuhisa |
| Middle name | |
| Last name | Fujii |
Organization
Tokyo Medical and Dental University
Division name
Division of urology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo,Japan
TEL
03-3813-6111
y-fujii.uro@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Nakayama |
Organization
Tokyo Medical and Dental University
Division name
Division of urology
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
nakayama.uro@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
self-sustaining
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Review Board of Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-6111
info.bec@tmd.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
| 2018 | Year | 04 | 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
| 2018 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 27 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research for immune environment for patients with bladder cancer
Management information
Registered date
| 2018 | Year | 01 | Month | 20 | Day |
Last modified on
| 2019 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035290
