Clinical trial 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.
Official title: 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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Immune System and Related Disorders
Keywords: immune system
environmental interactions
genetic component
Lead sponsor: Institut Pasteur
Sponsor class: INDUSTRY
First posted: 2019-04-24
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Immunological analysis
timeFrame: through study completion, an average of 4 year
Secondary outcomes:
measure: Genetic analysis
timeFrame: through study completion, an average of 4 year
measure: Microbiota analysis
timeFrame: through study completion, an average of 4 year
measure: Metabolomic analysis
timeFrame: through study completion, an average of 4 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre médical de l'Institut Pasteur
city: Paris
country: France
facility: Institut Pasteur
city: Paris
country: France
facility: Hopital sainte Périne
city: Paris
country: France
facility: Hôpital Tenon
Study officials:
affiliation: Institut Pasteur - ICAReB
name: Marie-Noelle Ungeheuer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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