Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-31 @ 7:09 AM
Study NCT ID:
NCT05381857
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2022-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'serum, plasma, urine, nasal swab, fecal samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 415}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-06', 'studyFirstSubmitDate': '2022-05-16', 'studyFirstSubmitQcDate': '2022-05-16', 'lastUpdatePostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify associations with immune response variability', 'timeFrame': '20 years', 'description': 'Identifying factors (genetic, epigenetic, immunological and environmental) that contributes to the observed heterogeneity in immune responses at the individual and population level over time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immune response', 'Immune system', 'genotype-to-phenotype association', 'genetic variability', 'reference-based population'], 'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '25562703', 'type': 'BACKGROUND', 'citation': 'Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. The Milieu Interieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3.'}, {'pmid': '24656047', 'type': 'BACKGROUND', 'citation': 'Duffy D, Rouilly V, Libri V, Hasan M, Beitz B, David M, Urrutia A, Bisiaux A, Labrie ST, Dubois A, Boneca IG, Delval C, Thomas S, Rogge L, Schmolz M, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Functional analysis via standardized whole-blood stimulation systems defines the boundaries of a healthy immune response to complex stimuli. Immunity. 2014 Mar 20;40(3):436-50. doi: 10.1016/j.immuni.2014.03.002.'}, {'pmid': '29476184', 'type': 'BACKGROUND', 'citation': 'Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jonsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Mar;19(3):302-314. doi: 10.1038/s41590-018-0049-7. Epub 2018 Feb 23.'}], 'seeAlsoLinks': [{'url': 'http://www.milieuinterieur.fr', 'label': 'The website provides a description of the Milieu Intérieur project, consortium and collaborative studies'}]}, 'descriptionModule': {'briefSummary': 'Effects of aging, genetics and environmental exposures on immune variation in a previously well-defined healthy population (NCT03905993).', 'detailedDescription': 'Susceptibility to infections, disease severity, and response to medical therapies and vaccines are highly variable from one individual to another.\n\nIndividual heterogeneity in the immune response can have an enormous impact on the likelihood to respond to therapy or the development of side effects secondary to vaccine administration. Because of the complexity of immune responses in the individual and within the population, it has not been possible thus far to define the parameters (genetic or environmental) that constitute a healthy immune system and its natural occurring variability.\n\nThe overall aim of the Milieu Intérieur study (NCT03905993) is to define the parameters that characterise a healthy immune response and its natural variation across individuals, and in doing so, inform clinical strategies for managing disease. To achieve this, in 2012, a total of 1000 healthy volunteers, descendants of mainland French persons for at least three generations, split equally by sex (1:1 sex ratio) and stratified across five-decades of life were recruited.\n\nWith the first data collection (clinical study), key fundamental insights were gained. The project has also established a rich sample and data repository, supporting ongoing integrative research in systems immunology and personalized medicine.\n\nTo provide a longitudinal assessment of the immune variation observed in the Milieu Intérieur cohort, this research aim to perform a follow-up study of the cohort, 10 years after the initial study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy adults subjects, aged from 30 to 79 years old that provided samples for the initial Milieu Intérieur study', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any individual that provided samples for the initial Milieu Intérieur study (NCT03905993)\n* Ability to give their informed consent in writing\n* Subjects who, according to the investigator, can and will comply with the requirements of the protocol.\n* Affiliated to the French social security or assimilated regimens\n\nExclusion Criteria:\n\n* Individuals benefiting from a legal protection measure\n* Individuals unable to express informed consent for participation\n* Pregnant and breastfeeding women'}, 'identificationModule': {'nctId': 'NCT05381857', 'acronym': 'MI-V3', 'briefTitle': 'Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Institut Pasteur'}, 'officialTitle': 'Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment', 'orgStudyIdInfo': {'id': '2020-062'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Individual from the initial Milieu Intérieur study', 'description': 'Individual who provided samples for the initial Milieu Intérieur study', 'interventionNames': ['Other: Human Biological Samples']}], 'interventions': [{'name': 'Human Biological Samples', 'type': 'OTHER', 'description': 'Blood, urine, nasal swab, fecal samples', 'armGroupLabels': ['Individual from the initial Milieu Intérieur study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Biotrial', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Lluis QUINTANA MURCI, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Pasteur'}, {'name': 'Darragh DUFFY, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institut Pasteur'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}