NCT03925272

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,200 (estimated)
• Sponsor: Institut Pasteur · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Accepted

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.

Conditions

• Immune System and Related Disorders

Interventions

Type	Name	Description
PROCEDURE	Collection of samples (blood, stool, etc.)
GENETIC	Genetic determinants analysis
PROCEDURE	Sample obtained after surgery performed in the context of care

Timeline

• Start date: 2011-02-02
• Primary completion: 2023-12-02
• Completion: 2023-12-02
• First posted: 2019-04-24
• Last updated: 2022-05-17

Locations

4 sites across 1 country: France