UMIN-ICDS 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

Email

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


Email

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

Email

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/icdr_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