UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045746 |
|---|---|
| Receipt number | R000052223 |
| Scientific Title | A cross-sectional study for healthcare parameters in adult men and women |
| Date of disclosure of the study information | 2021/10/14 |
| Last modified on | 2021/10/13 21:23:56 |
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Basic information
Public title
A cross-sectional study for healthcare parameters in adult men and women
Acronym
A cross-sectional study for healthcare parameters in adult men and women
Scientific Title
A cross-sectional study for healthcare parameters in adult men and women
Scientific Title:Acronym
A cross-sectional study for healthcare parameters in adult men and women
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate relationships with multiple healthcare parameters
Basic objectives2
Others
Basic objectives -Others
To investigate relationships with multiple healthcare parameters
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Search for relationships with multiple healthcare parameters
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
-Healthy adults
-Subjects who can answer questionnaire
-Subjects who have given written informed consent
Key exclusion criteria
-Subjects under hospital treatment
-Subjects who cannot visit clinic by oneself
- Subjects who have been diagnosed with dementia or are suspected of having dementia
->=60 years old and have not received COVID-19 vaccine
-Suspected of being infected with COVID-19
-Pacemaker users or pregnancies
-Subjects who have donated over 200 mL of blood within the last one month or over 400 mL of blood within the last three months
-Subjects who are judged to be inappropriate for the study by the medical doctor or investigator
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masanobu |
| Middle name | |
| Last name | Hibi |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
131-8501
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
TEL
+81-3-5630-7260
hibi.masanobu@kao.com
Public contact
Name of contact person
| 1st name | Toshiyasu |
| Middle name | |
| Last name | Tamura |
Organization
TES Holdings Co. Ltd
Division name
Department of Development for Clinical Trials
Zip code
110-0015
Address
Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, Japan
TEL
+81-3-6801-8480
Homepage URL
t.tamura@tes-h.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Preferred Networks, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Research Ethics Committee, Kao Corporation
Address
2-1-3 Bunka, Sumida-ku, Tokyo 131-8501, JAPAN
Tel
+81-3-5630-7263
morisaki.naoko@kao.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
うえのあさがおクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 14 | 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
| 2021 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To investigate relationships with multiple healthcare parameters
Management information
Registered date
| 2021 | Year | 10 | Month | 13 | Day |
Last modified on
| 2021 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052223
