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Creation of a Prospective Cohort of Healthy and Sick Subjects and of a Collection of Associated Biological Resources, for the Study of the Immune System and of Its Genetic and Environmental Determinants.

Constitution d'Une Cohorte Prospective de Sujets Sains et Malades et d'Une Collection de Ressources Biologiques associées Pour l'étude du système Immunitaire et de Ses déterminants Génétiques et Environnementaux

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03925272
Acronym
CoSImmGEn
Enrollment
2200
Registered
2019-04-24
Start date
2011-02-02
Completion date
2023-12-02
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune System and Related Disorders

Keywords

immune system, environmental interactions, genetic component

Brief summary

CoSImmGEn is a protocol set up to respond to the current lack of healthy and sick population cohorts. Biological resources from these cohorts allow researchers to study the immune system and its genetic and environmental determinants. Those cohorts and collections are open not only to the Pasteurian community but also to the worldwide scientific community (both public and private) working in the field.

Detailed description

The CoSImmGEn protocol is dedicated to the study of the immune system in healthy people or people with specific pathologies. It is composed of 6 arms (sub-cohorts): * Arm main cohort CoSImmGEn: comprised of 5 sub groups (A, B, C, D, M) of healthy adult subjects from various ethno-geographical origins. * Arm ancillary cohort P comprised of first-degree relatives (including parents, siblings, or children), whether they are healthy or ill. It will allow, whenever necessary, to remove allelic ambiguities for example for the study of HLA and MHC genes. * Arm ancillary cohort HS: comprised of subjects suffering from Suppurativa Hidradenitis (or Verneuil's disease.) The investigators will include patients suffering from this disease and their close relatives, in order to understand the genetic, immunological, microbiological and metabolomic bases of this disease. * Arm ancillary cohort J: comprised of elderly patients (≥ 65 years old) with Alzheimer's disease and with mild, moderate or severe cognitive impairment. It will help understand the role of the gut microbiota in age-related brain deficits. * Arm ancillary cohort F: comprised of patients with familial adenomatous polyposis and carrying a mutation of the APC (Adenomatous Polyposis Coli) tumor suppressor gene. That arm has been set up to carry out a pilot phase on the role of APC mutations on anti-tumoral immune response. * Arm ancillary cohort I: comprised of patients with chronic inflammatory diseases such as Ankylosing spondylitis and Crohn's disease. * Arm ancillary cohort V: comprised of subjects vaccinated against COVID-19. It will help to follow-up the immune response after vaccination against COVID-19 in the general population. Additional arms may be set up through new collaborations in the next few years to study others diseases in which the immune system intervenes, such as: infectious diseases, allergies or cancers.

Interventions

PROCEDURECollection of samples (blood, stool, etc.)
GENETICGenetic determinants analysis
PROCEDURESample obtained after surgery performed in the context of care

Sponsors

Institut Pasteur
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* unprotected adults with social security who have attested their consent after receiving any relevant information about the study * subjects whose ethno-geographical origin of both parents is known * subjects for whom data on principal vaccinations (diphtheria, tetanus, poliomyelitis, hepatitis B, possibly tuberculosis) are documented * subjects who consented to carry out serological tests HIV, HCV, HBV

Exclusion criteria

* Any conditions that would not allow participation in the present study, on the opinion of the investigator (documenting), ie any acute or chronic pathology that may interfere with the immune system, such as progressive or chronic pathology severe or uncontrolled by current treatments or a pathology requiring the administration of immune impact drugs: long-term anti-inflammatory, immunosuppressive, etc * Pregnant or lactating women * For the realization of skin biopsies: allergy to local anesthetics, cardiac valvulopathy * For the realization of Tubertest: Subject presenting a contraindication to tuberculin

Design outcomes

Primary

MeasureTime frameDescription
Immunological analysisthrough study completion, an average of 4 yearPercentage of blood cells harbouring morphological of functional abnormalities identified by flow cytometry and TrueCulture system analysis.

Secondary

MeasureTime frameDescription
Genetic analysisthrough study completion, an average of 4 yearIdentification of genetic factors implicated in or predisposing to specific diseases through gene expression quantification, targeted genotyping of exome sequencing or whole genome sequencing.
Microbiota analysisthrough study completion, an average of 4 yearIdentification of specific compositions of intestinal and/or cutaneous microbiota associated with specific diseases by metagenomic analysis.
Metabolomic analysisthrough study completion, an average of 4 yearQuantification of blood metabolites by mass spectrometry

Countries

France

Contacts

Primary ContactMarie-Noelle Ungeheuer, PhD
marie-noelle.ungeheuer@pasteur.fr+33 0140613581
Backup ContactHélène Laude, PhD
helene.laude@pasteur.fr+33 0145688395

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026