Ignite Creation Date:
2025-12-24 @ 9:29 PM
Ignite Modification Date:
2025-12-25 @ 7:14 PM
Study NCT ID:
NCT06268132
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2024-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longevity in Russia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, stool, saliva, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-20', 'studyFirstSubmitDate': '2024-02-13', 'studyFirstSubmitQcDate': '2024-02-13', 'lastUpdatePostDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality among long-living adults', 'timeFrame': 'at least 1 year after inclusion in the study', 'description': 'Mortality among long-living adults within at least 1 year after inclusion in the study and factors associated with mortality will be assessed.'}, {'measure': 'Morbidity among long-living adults', 'timeFrame': 'at least 1 year after inclusion in the study', 'description': 'Morbidity among long-living adults within at least 1 year after inclusion in the study and factors associated with morbidity will be assessed.'}], 'secondaryOutcomes': [{'measure': 'Aging phenotypes', 'timeFrame': 'at least 2 years after inclusion in the study', 'description': 'Identification of successful and unsuccessful aging phenotypes'}, {'measure': 'Social, economic, and medical- history-related determinants', 'timeFrame': 'at least 2 years after inclusion in the study', 'description': 'Identification of social, economic, and medical- history-related determinants of successful and unsuccessful aging, geriatric syndromes'}, {'measure': 'Genetic determinants', 'timeFrame': 'at least 2 years after inclusion in the study', 'description': 'Identification of the genetic determinants of successful and unsuccessful aging, geriatric syndromes'}, {'measure': 'Epigenetic determinants', 'timeFrame': 'at least 2 years after inclusion in the study', 'description': 'Identification of the epigenetic determinants (methylation sites) of successful and unsuccessful aging, geriatric syndromes'}, {'measure': 'Metagenomic determinants', 'timeFrame': 'at least 2 years after inclusion in the study', 'description': 'Identification of the metagenomic determinants (16S-rSeq) of successful and unsuccessful aging, geriatric syndromes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['LONGEVITY 1', 'Frailty', 'Aging', 'Age-related Cognitive Decline', 'Aging Disorder']}, 'descriptionModule': {'briefSummary': 'This is an observational cohort study of long-living adults (participants aged 90 and above) from the Central Federal District of Russia.\n\nThe 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.\n\nThe 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.', 'detailedDescription': '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.\n\nFollow-up checks will be carried out once a year by phone or during additional visits.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '90 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The inclusion of participants will be carried out with the involvement of social services, boarding houses for labor veterans, geriatric centers and other geriatric services in the central region of Russia', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* 90 years of age or above\n\nExclusion Criteria:\n\n* Refusal to participate or to provide informed consent;\n* Any other criteria deemed reasons for exclusion by the Principal Investigator.'}, 'identificationModule': {'nctId': 'NCT06268132', 'briefTitle': 'Longevity in Russia', 'organization': {'class': 'OTHER', 'fullName': 'Center for Strategic Planning, of the Federal Medical and Biological Agency'}, 'officialTitle': 'Healthy Longevity and Mortality in Long-living Adults: Contributors and Causes - Lifestyle, Socioeconomic Background, and Replicative Aging', 'orgStudyIdInfo': {'id': 'MLS90'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long-living individuals', 'description': 'Long-living individuals at least 90 years of age from the Central Federal District of Russia'}]}, 'contactsLocationsModule': {'locations': [{'zip': '129226', 'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Irina D. Strazhesko, M.D., Ph.D', 'role': 'CONTACT', 'email': 'Istrazhesko@gmail.com', 'phone': '+7 (499) 187-64-67'}], 'facility': 'RUSSIAN CLINICAL AND RESEARCH CENTER OF GERONTOLOGY, Pirogov Russian National Research Medical University of the Ministry of Healthcare of the Russian Federation', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Daria A. Kashtanova, M.D., Ph.D', 'role': 'CONTACT', 'email': 'DKashtanova@cspfmba.ru', 'phone': '+74955406171', 'phoneExt': '4120'}, {'name': 'Veronika V. Erema, M.D., Ph.D', 'role': 'CONTACT', 'email': 'VErema@cspfmba.ru', 'phone': '+7 (495) 540-61-71', 'phoneExt': '4136'}], 'overallOfficials': [{'name': 'Irina D. Strazhesko, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pirogov Russian National Research Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Strategic Planning, of the Federal Medical and Biological Agency', 'class': 'OTHER'}, 'collaborators': [{'name': 'Pirogov Russian National Research Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}