UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036559 |
|---|---|
| Receipt number | R000041596 |
| Scientific Title | Study for stress markers in urinary of healthy subjects |
| Date of disclosure of the study information | 2019/04/22 |
| Last modified on | 2023/01/13 14:19:57 |
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Basic information
Public title
Study for stress markers in urinary of healthy subjects
Acronym
Study for stress markers in urinary of healthy subjects
Scientific Title
Study for stress markers in urinary of healthy subjects
Scientific Title:Acronym
Study for stress markers in urinary of healthy subjects
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Understanding temporal transition of urinary stress markers
Basic objectives2
Others
Basic objectives -Others
Relationship between stress questionnaire results and urinary stress markers
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
temporal transition of urinary stress markers
Key secondary outcomes
Relationship between stress questionnaire results and urinary stress markers
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
| 22 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1 Japanese
2 Age 22-49
3 Laborer
4 Those who can visit the hospital twice for urine collection
5 Healthy adult
6 Do not perform sexual acts, masturbating, etc. the day before the urine collection to the urine collection
7 agree to this study
Key exclusion criteria
1 During menstruation
2 Pregnant or nursing women
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Arata |
| Middle name | |
| Last name | Oh-Nishi |
Organization
RESVO.inc
Division name
representative
Zip code
210-0007
Address
Kawasaki Frontier Building 4F, 11-2 Ekimae Honmachi, Kawasaki-ku, Kawasaki-shi, Kanagawa , Japan
TEL
080-7832-3818
arata@resvo-inc.com
Public contact
Name of contact person
| 1st name | arata |
| Middle name | |
| Last name | Oh-Nishi |
Organization
RESVO.inc
Division name
representative
Zip code
210-0007
Address
Kawasaki Frontier Building 4F, 11-2 Ekimae Honmachi, Kawasaki-ku, Kawasaki-shi, Kanagawa,Japan
TEL
080-7832-3818
Homepage URL
arata@resvo-inc.com
Sponsor or person
Institute
RESVO Inc.
Institute
Department
Personal name
Funding Source
Organization
RESVO Inc.
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
Leave a Nest Co.,Ltd Ethics Review Board
Address
162-0822 Iidabashi Miyuki Building, 1-4 Shimomiyahicho, Shinjuku-ku, Tokyo,Japan
Tel
03-5227-4198
arata@resvo-inc.com
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
| 2019 | Year | 04 | Month | 22 | 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
Completed
Date of protocol fixation
| 2019 | Year | 02 | Month | 27 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Confirmation of correlation between stress check questionnaire and stress markers in urine.
Management information
Registered date
| 2019 | Year | 04 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041596
