Genetic & Environmental Determinants Of Immune Phenotype Variance: A Longitudinal Assessment

NCT05381857 | Completed DMC

• 1 other identifier: 2020-062
• Study Type: observational
• Target: 415
• Locations: 1 country
• Sites: 1

Brief Summary

Effects of aging, genetics and environmental exposures on immune variation in a previously well-defined healthy population (NCT03905993).

Conditions

Healthy Subjects

Keywords

Immune response; Immune system; genotype-to-phenotype association; genetic variability; reference-based population

Outcome Measures

Primary Outcomes (1)

• Identify associations with immune response variability

  Identifying factors (genetic, epigenetic, immunological and environmental) that contributes to the observed heterogeneity in immune responses at the individual and population level over time

  20 years

Study Arms (1)

Individual from the initial Milieu Intérieur study

Individual who provided samples for the initial Milieu Intérieur study

Other: Human Biological Samples

Interventions

Human Biological Samples OTHER

Blood, urine, nasal swab, fecal samples

Individual from the initial Milieu Intérieur study

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adults subjects, aged from 30 to 79 years old that provided samples for the initial Milieu Intérieur study

You may qualify if:

• Any individual that provided samples for the initial Milieu Intérieur study (NCT03905993)
• 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

You may not qualify if:

• Individuals benefiting from a legal protection measure
• Individuals unable to express informed consent for participation
• Pregnant and breastfeeding women

Sponsors & Collaborators

• Institut Pasteur: lead

Study Sites (1)

Biotrial

Rennes, 35042, France

Location

Related Publications (3)

• 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: 25562703 BACKGROUND

• 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: 24656047 BACKGROUND

• 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.

  PMID: 29476184 BACKGROUND

Related Links

• The website provides a description of the Milieu Intérieur project, consortium and collaborative studies

Biospecimen

Retention: SAMPLES WITH DNA

serum, plasma, urine, nasal swab, fecal samples

Study Officials

• Lluis QUINTANA MURCI, PhD

  Institut Pasteur

  STUDY DIRECTOR

• Darragh DUFFY, PhD

  Institut Pasteur

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: March 15, 2022
• Primary Completion: October 13, 2022
• Study Completion: October 13, 2022
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

FR (1)