UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045789 |
|---|---|
| Receipt number | R000052275 |
| Scientific Title | Exploratory clinical studies to obtain detailed digital and bioinformation data to investigate common characteristics of healthy super-elderly people |
| Date of disclosure of the study information | 2021/10/18 |
| Last modified on | 2024/03/26 15:22:01 |
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Basic information
Public title
Exploratory clinical studies to obtain detailed digital and bioinformation data to investigate common characteristics of healthy super-elderly people
Acronym
Exploratory clinical studies to obtain detailed digital and bioinformation data to investigate common characteristics of healthy super-elderly people
Scientific Title
Exploratory clinical studies to obtain detailed digital and bioinformation data to investigate common characteristics of healthy super-elderly people
Scientific Title:Acronym
Exploratory clinical studies to obtain detailed digital and bioinformation data to investigate common characteristics of healthy super-elderly people
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Key objective: Examining the feasibility of collecting digital data and samples from the very elderly
Basic objectives2
Others
Basic objectives -Others
Secondary purpose: Examining the possibility of recruiting the super-elderly
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acquisition rate of digital data and sample collection data from super-elderly people
Key secondary outcomes
Confirmation of distribution of biomarkers that are considered to be targets
Selection of indicators related to lifestyle evaluation
Registration rate by age group for the number of consents obtained
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Men and women who are 80 years old or older at the time of obtaining consent
2) Those who have obtained written consent to participate in this study
3) Persons who have obtained written consent in a separate document regarding the implementation of genetic testing
4) Those who can wear a wearable device while sleeping
5) Those who can charge the wearable device by themselves or their family
6) Those who can perform simple operations by touching the screen on a loaned tablet
Key exclusion criteria
1) Persons who have been certified as requiring long-term care
2) Persons with apparently impaired cognitive function
3) Persons with a medical history or current medical history that causes cognitive decline
4) Persons with clinically significant illness
5) Those who have participated in clinical research and clinical trials of other drugs and foods within the past month
6) Persons judged by the principal investigator or coordinator to be inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Hirotaka |
| Middle name | |
| Last name | Nagashima |
Organization
Medical Corporation Chiseikai
Division name
Clinical Trial Center
Zip code
103-0028
Address
KT Bldg.2F, 1-1-8 Yaesu,Chuo-ku,Tokyo 103-0028,JAPAN
TEL
0332766935
nagashima_hirotaka@tc-clinic.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | Svensson |
| Last name | Kishi |
Organization
The University of Tokyo
Division name
Precision Health Department of Bioengineering,Graduate School of Engineering
Zip code
113-8656
Address
7-3-1Hongo,Bunkyo-ku,Tokyo
TEL
03-5841-4737
Homepage URL
https://precision.t.u-tokyo.ac.jp/
kishi@bioeng.t.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Akiko Svensson Kishi
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minami-Ikebukuro. Toshima-ku, Tokyo 171-0022,JAPAN
Tel
03-6868-7022
jccr-info@jccr,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
| 2021 | Year | 10 | Month | 18 | 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
| 2021 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 10 | Month | 18 | Day |
Last modified on
| 2024 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052275
