NCT03541460

Brief Summary

This study will systematically assess epigenome methylation changes in participants of the Israel multi-ethnic centenarian study cohort, which includes citizens of Israel aged 95 years and older, compared to their offspring and younger controls.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

May 30, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

7 years

First QC Date

January 10, 2017

Last Update Submit

April 2, 2023

Conditions

Keywords

centenariansepigenomelongevityhealthy agingepigenetic

Outcome Measures

Primary Outcomes (1)

  • Frequency of alleles in genes across the genome

    Variations of frequency of alleles in study groups using dedicated software for genomic analysis.

    6 months

Study Arms (2)

Older Cohort

Demographic, health and functional data will be collected from subjects 95 years and older by means of a structured interview. Blood will be collected for laboratory and genetic testing.

Younger Controls

Demographic, health and functional data will be collected from the children of the older subjects and other aged-matched controls by means of a structured interview. Blood will be collected for laboratory and genetic testing.

Eligibility Criteria

Age95 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects aged 95 years and older will form the study cohort. Control group will comprise children of the older subjects and age-matched controls.

You may qualify if:

  • Aged 95 years and older.
  • Provide verbal consent for participation in the study.
  • Cognitively able to provide consent and answer a structured questionnaire.

You may not qualify if:

  • Not able to provide consent for participation in the study.
  • Impaired consciousness.
  • Unable to communicate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Health Care Campus

Haifa, North, 3109601, Israel

Location

Related Publications (3)

  • Brooks-Wilson AR. Genetics of healthy aging and longevity. Hum Genet. 2013 Dec;132(12):1323-38. doi: 10.1007/s00439-013-1342-z. Epub 2013 Aug 8.

    PMID: 23925498BACKGROUND
  • Evert J, Lawler E, Bogan H, Perls T. Morbidity profiles of centenarians: survivors, delayers, and escapers. J Gerontol A Biol Sci Med Sci. 2003 Mar;58(3):232-7. doi: 10.1093/gerona/58.3.m232.

    PMID: 12634289BACKGROUND
  • Wojdacz TK, Hansen LL. Techniques used in studies of age-related DNA methylation changes. Ann N Y Acad Sci. 2006 May;1067:479-87. doi: 10.1196/annals.1354.069.

    PMID: 16804030BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Three 10 ml blood samples will be drawn into vacutainer tubes (Yellow top with anticoagulant; speckled top without anticoagulant). Blood samples will be analyzed for the levels of hemoglobin, hematocrit, white blood cell counts, and levels of glucose, insulin, albumin, inflammatory markers, and plasma lipids. CD34+Lin- cells will be isolated from the peripheral blood specimen using immuno-magnetic separation technique, followed by cell sorter. Mononuclear cells are separated by Ficoll-Paque density gradient, and CD34+ cells obtained by positive immuno-magnetic bead selection, using Macs columns (Miltenyi Biotech). The purified cells are then subjected to a cell sorter following immunostaining. The isolated cells will be cryopreserved in 10% DMSO by controlled rate freezing.

Study Officials

  • Tzvi Dwolatzky, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Geriatric Medicine

Study Record Dates

First Submitted

January 10, 2017

First Posted

May 30, 2018

Study Start

January 1, 2016

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Individual Participant Data (IPD) will not be shared

Locations