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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06268132
Other study ID # MLS90
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 25, 2019
Est. completion date December 31, 2025

Study information

Verified date February 2024
Source Center for Strategic Planning, of the Federal Medical and Biological Agency
Contact Daria A. Kashtanova, M.D., Ph.D
Phone +74955406171
Email DKashtanova@cspfmba.ru
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia. The study seeks to determine the genetic and cellular and molecular determinants of healthy longevity and to assess the impact of lifestyle and socioeconomic and environmental factors on healthy longevity. The study is expected to result in the development of a panel of markers of healthy longevity and/or a model of healthy aging based on the analysis of all factors under consideration.


Description:

The study involves a long-term observation of a cohort of long-living adults. During the first visit, a medical professional will take a detailed medical history and perform a comprehensive geriatric assessment (for 15 geriatric syndromes), and physical examination. The participants will have their biomaterials sampled for basic and extended blood biochemistry testing, telomere length measurement, common urine tests and subsequent biobanking and additional studies: whole genome sequencing, DNA methylation analysis, transcriptome analysis, and 16S RNA sequencing of stool and saliva. Follow-up checks will be carried out once a year by phone or during additional visits. The study seeks to identify the genetic, epigenetic, and metagenomic determinants associated with the successful and unsuccessful aging phenotypes, mortality, and survival in long-living individuals.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
Est. completion date December 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender All
Age group 90 Years and older
Eligibility Inclusion Criteria: - Informed consent - 90 years of age or above Exclusion Criteria: - Refusal to participate or to provide informed consent; - Any other criteria deemed reasons for exclusion by the Principal Investigator.

Study Design


Locations

Country Name City State
Russian Federation RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation Moscow

Sponsors (2)

Lead Sponsor Collaborator
Center for Strategic Planning, of the Federal Medical and Biological Agency Pirogov Russian National Research Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality among long-living adults Mortality among long-living adults within at least 1 year after inclusion in the study and factors associated with mortality will be assessed. at least 1 year after inclusion in the study
Primary Morbidity among long-living adults Morbidity among long-living adults within at least 1 year after inclusion in the study and factors associated with morbidity will be assessed. at least 1 year after inclusion in the study
Secondary Aging phenotypes Identification of successful and unsuccessful aging phenotypes at least 2 years after inclusion in the study
Secondary Social, economic, and medical- history-related determinants Identification of social, economic, and medical- history-related determinants of successful and unsuccessful aging, geriatric syndromes at least 2 years after inclusion in the study
Secondary Genetic determinants Identification of the genetic determinants of successful and unsuccessful aging, geriatric syndromes at least 2 years after inclusion in the study
Secondary Epigenetic determinants Identification of the epigenetic determinants (methylation sites) of successful and unsuccessful aging, geriatric syndromes at least 2 years after inclusion in the study
Secondary Metagenomic determinants Identification of the metagenomic determinants (16S-rSeq) of successful and unsuccessful aging, geriatric syndromes at least 2 years after inclusion in the study
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