UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049725 |
|---|---|
| Receipt number | R000056638 |
| Scientific Title | Investigation of the accuracy and physiological significance of body temperature fluctuations measured by continuous body temperature measurement devices and the relevance of circadian transition in peripheral blood immune cells |
| Date of disclosure of the study information | 2023/02/01 |
| Last modified on | 2023/12/09 09:27:17 |
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Basic information
Public title
Investigation of the accuracy and physiological significance of body temperature fluctuations measured by continuous body temperature measurement devices and the relevance of circadian transition in peripheral blood immune cells
Acronym
Investigating the relationship between the accuracy of continuous body temperature measurement devices and immune cells.
Scientific Title
Investigation of the accuracy and physiological significance of body temperature fluctuations measured by continuous body temperature measurement devices and the relevance of circadian transition in peripheral blood immune cells
Scientific Title:Acronym
Investigating the relationship between the accuracy of continuous body temperature measurement devices and immune cells.
Region
| Japan |
Condition
Condition
Healthy control and febrile disease
Classification by specialty
| Medicine in general | Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the correlation and accuracy of each of the devices capable of measuring continuous body temperature. In addition, the objective is to further examine the relationship with transition of immune indices.
Basic objectives2
Others
Basic objectives -Others
Consideration of device accuracy
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Continuously measured body temperature data and blood cell data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Groups with stress test
Interventions/Control_2
Groups without stress test
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
1. healthy subjects over 20 y/o
2. patients with a febrile disease over 20 y/o
3. who understand the content of this study and are able to obtain written consent
Key exclusion criteria
1. difficulty in communicating
2. Other subjects deemed unsuitable by the person in charge
Target sample size
27
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Kaneko |
Organization
Department of Internal Medicine, School of Medicine, Keio University
Division name
Division of Rheumatology
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3786
ykaneko.z6@keio.jp
Public contact
Name of contact person
| 1st name | Shuntaro |
| Middle name | |
| Last name | Saito |
Organization
Department of Internal Medicine, School of Medicine, Keio University
Division name
Division of Rheumatology
Zip code
160-8582
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
TEL
03-5363-3786
Homepage URL
shsaito@keio.jp
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Funding Source
Organization
Keio University
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
Keio University hospital IRB
Address
35 Shinanomachi, Shinjyuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2023 | Year | 02 | 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
24
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
| 2022 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 22 | Day |
Date trial data considered complete
| 2023 | Year | 11 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056638
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
