Milieu Intérieur Collection - Genetic & Environmental Determinants Of Immune Phenotype Variance (MI)
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|ClinicalTrials.gov Identifier: NCT03905993|
Recruitment Status : Completed
First Posted : April 8, 2019
Last Update Posted : April 8, 2019
|Condition or disease|
|Individuality Healthy Subjects|
Susceptibility to infections, disease severity, and response to medical therapies and vaccines are highly variable from one individual to another. While the question of variance in human populations continues to be a focal point of scientific research, medical practices and public health policies typically take a 'one size fits all' model to disease management and drug development.
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.
Efforts to restore the 'personal' in medical care are the current challenge, and the driving vision of the project, to which the current study belongs.
In order to realize the promise of personalized medicine, an in-depth understanding of the determinants of heterogeneity in host response to stress is required. The Milieu Interieur cohort was established to address these questions through a population systems immunology approach.
|Study Type :||Observational|
|Actual Enrollment :||956 participants|
|Official Title:||Genetic & Environmental Determinants Of Immune Phenotype Variance: Establishing A Path Towards Personalized Medicine|
|Actual Study Start Date :||September 17, 2012|
|Actual Primary Completion Date :||August 8, 2013|
|Actual Study Completion Date :||August 8, 2013|
Experimental: unique group.
At V0: 1238 subjects were screened At V1: 1012 subjects (12 later withdrew) gave the following samples: blood, nasal swab,stool. 323 subjects among 1000 gave one additional sample (Skin Biopsy) At V2: 504 subjects came at V2 to perform blood, nasal swab and stool samples
- Identify genetic associations with immune response variability [ Time Frame: 2024 ]Genome wide associations studies that combine whole genome genotyping data sets with immune response phenotypes to identify genetic regulators of immune function. These studies will be later completed with data from whole genome sequencing for more detailed genetic analysis.
- Identify environmental associations with immune response variability [ Time Frame: 2026 ]Association of whole metagenomic data sets generated from fecal samples that reflect environmental exposures with immune response phenotypes.
Biospecimen Retention: Samples With DNA
- DNA extracted from whole blood
Whole blood stimulations for 40 TruCulture stimulation conditions from which there are
- Trizol stabilized cell pellets and/or extracted RNA
- Culture supernatants in aliquots
- Fecal samples and extracted DNA
- Nasal swab samples, extracted DNA and liquid supernatant
- Plasma from whole blood
- Frozen PBMCs
- Fibroblast cell lines (322 donors) and derived iPSCs (4 donors)
- EBV cell lines (203 donors)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03905993
|Principal Investigator:||Lluis Quintana-Murci, PhD||Institut Pasteur|