Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment
NCT ID: NCT05381857
Last Updated: 2023-07-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
415 participants
OBSERVATIONAL
2022-03-15
2022-10-13
Brief Summary
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Detailed Description
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Individual 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.
The 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.
With 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.
To 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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Individual from the initial Milieu Intérieur study
Individual who provided samples for the initial Milieu Intérieur study
Human Biological Samples
Blood, urine, nasal swab, fecal samples
Interventions
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Human Biological Samples
Blood, urine, nasal swab, fecal samples
Eligibility Criteria
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Inclusion Criteria
* Ability to give their informed consent in writing
* Subjects who, according to the investigator, can and will comply with the requirements of the protocol.
* Affiliated to the French social security or assimilated regimens
Exclusion Criteria
* Individuals unable to express informed consent for participation
* Pregnant and breastfeeding women
30 Years
79 Years
ALL
Yes
Sponsors
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Institut Pasteur
INDUSTRY
Responsible Party
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Principal Investigators
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Lluis QUINTANA MURCI, PhD
Role: STUDY_DIRECTOR
Institut Pasteur
Darragh DUFFY, PhD
Role: STUDY_DIRECTOR
Institut Pasteur
Locations
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Biotrial
Rennes, , France
Countries
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References
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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.
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.
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.
Related Links
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The website provides a description of the Milieu Intérieur project, consortium and collaborative studies
Other Identifiers
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2020-062
Identifier Type: -
Identifier Source: org_study_id
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