UMIN-CTR Clinical Trial
| Recruitment status | Open public recruiting |
| Unique ID issued by UMIN | UMIN000040446 |
| Receipt No. | 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 (Ver. 1) |
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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) | |
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| Condition | |||||||||
| Condition | healthy longevity | ||||||||
| Classification by specialty |
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| 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 | |
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| Eligibility | ||||
| Age-lower limit |
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| Age-upper limit |
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| 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. |
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| Key exclusion criteria | Too frail or ill to participate | |||
| Target sample size | 1700 | |||
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| Name of lead principal investigator |
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| 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 |
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| 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 | |
| Institute | Keio University School of Medicine |
| Institute | |
| Department | |
| 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） |
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| Date of disclosure of the study information |
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| 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. |
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| Results date posted |
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| 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. |
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| 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. |
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| Adverse events | none |
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| Outcome measures | 1. all-cause and cause^specific mortality 2. Incidental disability, dementia, and age-related diseases. |
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| 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 | ||||||
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| 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. |
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| Last modified on |
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| Link to view the page | |
| URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046149 |
