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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036559
Receipt No. 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 2019/04/20

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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 Norifumi
Middle name
Last name Kobayashi
Organization RESVO.inc
Division name representative
Zip code 144-0042
Address 7-1-204, Haneda-Asahicho, Ota-Ku, Tokyo 144-0022, Japan
TEL 050-5308-8561
Email yoshifumi@resvo-inc.com

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Kojima
Organization REVO Inc.
Division name Development Div.
Zip code 144-0042
Address 7-1-204, Haneda-Asahicho, Ota-Ku, Tokyo 144-0022, Japan
TEL 050-5308-8561
Homepage URL
Email takayuki@resvo-inc.com

Sponsor
Institute RESVO Inc.
Institute
Department

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 RESVO Inc. Ethics Committee
Address 7-1-204, Haneda-Asahicho, Ota-Ku, Tokyo 144-0022, Japan
Tel 050-5308-8561
Email yoshifumi@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 Open public recruiting
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 07 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
2019 Year 04 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041596

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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