UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040446 |
|---|---|
| Receipt number | R000046149 |
| Scientific Title | Interdisciplinary Centenarian and Semi-supercentenarian Study in Japan Part 1: the genetic study for healthy longevity |
| Date of disclosure of the study information | 2020/05/26 |
| Last modified on | 2020/05/19 13:34:31 |
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Basic information
Public title
Interdisciplinary Centenarian and Semi-supercentenarian Study in Japan Part 1: the genetic study for healthy longevity
Acronym
Japan Centenarian and Semi-supercentenarian Study Part 1 (genetic study)
Scientific Title
Interdisciplinary Centenarian and Semi-supercentenarian Study in Japan Part 1: the genetic study for healthy longevity
Scientific Title:Acronym
Japan Centenarian and Semi-supercentenarian Study Part 1 (genetic study)
Region
| Japan |
Condition
Condition
healthy longevity
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology | Neurology | Geriatrics |
| Psychiatry | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to identify genetic determinants of healthy longevity by using genomes from centenariansand semisupercentenarians. Our genetic analysis includes SNPs, exome, whole genome sequences, and epigenetics, transcriptomes, and telomere length.
Basic objectives2
Others
Basic objectives -Others
The identification of protective genes for age-related diseases such as dementia and frailty.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
all cause and cause-specific mortality
Key secondary outcomes
incident disability, dementia, and chronic disease of aging
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
| 100 | years-old | <= |
Age-upper limit
| 125 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Centenarians: those who ages between 100 and 104 years old at enrollment
Semi-supercentenarians: those who ages 105 years and older at enrollment.
There is no upper limit for age at enrollment.
Key exclusion criteria
Too frail or ill to participate
Target sample size
1700
Research contact person
Name of lead principal investigator
| 1st name | Yasumichi |
| Middle name | |
| Last name | Arai |
Organization
Keio University School of Medicine
Division name
Center for Supercentenarian Medical Research
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
81352692468
yasumich@keio.jp
Public contact
Name of contact person
| 1st name | Yasumichi |
| Middle name | |
| Last name | Arai |
Organization
Keio University School of Medicine
Division name
Center for Supercentenarian Medical Research
Zip code
160-8582
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
81352692468
Homepage URL
http://www.keio-centenarian.com/
yasumich@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and development (AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Keio Global Research Institute, Keio University
Name of secondary funder(s)
Ministry of Education, Culture, Sports, Science and Technology
Ministry of Health, Labor and Welfare
Ministry of Agriculture, Forestry, and Fisheries
IRB Contact (For public release)
Organization
the Ethics committee of the Keio University School of Medicine
Address
35, Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
81353633503
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
慶應義塾大学医学部（東京都）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
http://www.keio-centenarian.com/
Number of participants that the trial has enrolled
930
Results
1. In 535 very old individuals and 930 centenarians, the frequency of APOE E4 allele was inversely correlated with age. Additionally, APOE E4 allele in centenarian men was significantly lower than that in centenarian women.
2. In a single cell trascriptome analysis of peripheral blood mononuclear cells, derived from 7 supercentenarians and 5 younger controls, we identified identified a marked increase of cytotoxic CD4 T cells (CD4 cytotoxic T lymphocytes) as a signature of supercentenarians.
Results date posted
| 2020 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2005 | Year | 08 | Month | 10 | Day |
Baseline Characteristics
Centenarians, semi-supercentenarians and their offspring and unrelated family living in Japan are enrolled in this study.
Most of centenarians are female, and characterized by low prevalence of diabetes.
Participant flow
A toatal of 304 centenarians living in Tokyo (65 men, 239 women) were enrolled in the Tokyo Centenarian Study between 2000-2002.
Subsequently, more than 600 semi-supercentenarians living in the whole country in Japan has been recruited for the Japan Semi-supercentenarian Study (JSS) since 2002. The recruitment of JSS is still opening.
Vital status of the study participants are followed annually by telephone of mail.
Adverse events
none
Outcome measures
1. all-cause and cause^specific mortality
2. Incidental disability, dementia, and age-related diseases.
Plan to share IPD
Part of raw data are deposited in national database (NBDC).
IPD sharing Plan description
https://humandbs.biosciencedbc.jp/en/hum0229-v1
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2000 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2000 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2000 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
This is a part of observational studies of centenarians and semi-supercentenarians living n Japan, which aims to identify genetic determinant of healthy longevity.
Management information
Registered date
| 2020 | Year | 05 | Month | 19 | Day |
Last modified on
| 2020 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046149
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