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. (CoSImmGEn)

May 16, 2022 updated by: Institut Pasteur

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"

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

2200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
      • Paris, France, 75015
      • Paris, France, 75015
        • Recruiting
        • Institut Pasteur
      • Paris, France, 75016
        • Recruiting
        • Hopital sainte Périne
        • Contact:
        • Principal Investigator:
          • Dany Vythilingum, MD
        • Principal Investigator:
          • Joelle Brachat, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with Suppurated Hidradenitis

Human biological samples :

Whole blood and derived products (DNA, RNA), urine, stool, saliva, tears, skin and mouth swabs, lesion samples: swab for microbiological analyzes, cutaneous biopsies (lesion skin and peri-lesional healthy skin), surgical lesion excisions, nasal swab, oro-pharyngeal swab, nasopharyngeal swab.

bio-clinical data: Ethno-geographical, family and personal antecedents and current events in particular related to Verneuil's disease and any associated diseases (chronic auto-inflammatory ...)
Procedure: Collection of samples (blood, stool, etc.)
Genetic: Genetic determinants analysis
Procedure: Sample obtained after surgery performed in the context of care
EXPERIMENTAL: Patients with Alzheimer disease

Human biological samples :

stool, blood (20 ml), nasal swab, oro-pharyngeal swab, nasopharyngeal swab.

bio-clinical data: healthy or sick status,cognitive, memory and psychometric abilities evaluated by different tests example: MMSE (for Alzheimer's) and MST (minor memory disorders), Psychometric abilities assessed by the Geriatric Depression Scale GDS, Nutritional status assessed by the MNA test
Procedure: Collection of samples (blood, stool, etc.)
Genetic: Genetic determinants analysis
EXPERIMENTAL: Patients with familial adenomatous polyposis

Human biological samples :

whole blood (30 to 100 mL), optional stool collection

bio-clinical data: Age, Gender, Ethnicity, Personal and Family Medical History, Current Treatment, Type of PAF Mutation
Procedure: Collection of samples (blood, stool, etc.)
Genetic: Genetic determinants analysis
EXPERIMENTAL: Patients with chronic inflammatory diseases (SPA, Crohn, ...)

Human biological samples :

whole blood and derived products (DNA, RNA, PBMC, plasma, serum), (100 mL), stool; as part of the treatment, occasionally: lesions, urine, saliva, tears

Bio-clinical data :

Ethno-geographical origin, Personal and family history, History of the disease, Associated or concomitant diseases, Treatments in progress.
Procedure: Collection of samples (blood, stool, etc.)
Genetic: Genetic determinants analysis
Procedure: Sample obtained after surgery performed in the context of care
EXPERIMENTAL: Healthy cases

Human biological samples :

whole blood and derived products: serum, plasma, DNA, RNA, PBMCs, T and B lymphocytes, monocytes / dendritic cells derived, other subpopulations (PMN, NK, etc.), urine, stool, saliva, tears, oral swabs, cutaneous swabs (healthy and injured), cutaneous biopsies (healthy and injured) and their derivatives (RNA, histological blocks ...), surgical excisions, nasal swab, oro-pharyngeal swab, nasopharyngeal swab.

Bio-clinical data :

ethno-geographical origin (5 groups), family and personal antecedents and contemporary events visits, in particular related to the immune system, infections, vaccinations, exposure factors (travel, lifestyles, stress, pollution cancers, allergies , chronic inflammatory diseases ...
Procedure: Collection of samples (blood, stool, etc.)
Genetic: Genetic determinants analysis
EXPERIMENTAL: Healthy cases relatives

Human biological samples :

whole blood and derived products: serum, plasma, DNA, RNA, PBMCs, T and B lymphocytes, monocytes / dendritic cells derived, other subpopulations (PMN, NK, etc.), urine, stool, saliva, tears, oral swabs, cutaneous swabs (healthy and injured), cutaneous biopsies (healthy and injured) and their derivatives (RNA, histological blocks ...), surgical excisions, nasal swab, oro-pharyngeal swab, nasopharyngeal swab.

Bio-clinical data :

ethno-geographical origin (5 groups), family and personal antecedents and contemporary events visits, in particular related to the immune system, infections, vaccinations, exposure factors (travel, lifestyles, stress, pollution cancers, allergies , chronic inflammatory diseases ...
Procedure: Collection of samples (blood, stool, etc.)
Genetic: Genetic determinants analysis
EXPERIMENTAL: Subjects vaccinated against COVID-19

Human biological samples :

whole blood and derived products: serum, DNA, PBMCs, saliva, nasopharyngeal swab

Bio-clinical data :

ethno-geographical origin, family and personal antecedents and contemporary events visits, in particular related to the immune system, infections, vaccinations, exposure factors (travel, lifestyles, stress, pollution cancers, allergies , chronic inflammatory diseases, specific history of otorhinolaryngology and broncho-pulmonary and treatments, specific COVID-19 history, risk factor for a severe form of COVID-19, symptoms of COVID-19 or positive test for SarsCov-2 positive
Procedure: Collection of samples (blood, stool, etc.)
Genetic: Genetic determinants analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immunological analysis
Time Frame: through study completion, an average of 4 year
Percentage of blood cells harbouring morphological of functional abnormalities identified by flow cytometry and TrueCulture system analysis.
through study completion, an average of 4 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Genetic analysis
Time Frame: through study completion, an average of 4 year
Identification of genetic factors implicated in or predisposing to specific diseases through gene expression quantification, targeted genotyping of exome sequencing or whole genome sequencing.
through study completion, an average of 4 year
Microbiota analysis
Time Frame: through study completion, an average of 4 year
Identification of specific compositions of intestinal and/or cutaneous microbiota associated with specific diseases by metagenomic analysis.
through study completion, an average of 4 year
Metabolomic analysis
Time Frame: through study completion, an average of 4 year
Quantification of blood metabolites by mass spectrometry
through study completion, an average of 4 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Pasteur

Investigators

  • Principal Investigator: Marie-Noelle Ungeheuer, PhD, Institut Pasteur - ICAReB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2011

Primary Completion (ANTICIPATED)

December 2, 2023

Study Completion (ANTICIPATED)

December 2, 2023

Study Registration Dates

First Submitted

April 9, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (ACTUAL)

April 24, 2019

Study Record Updates

Last Update Posted (ACTUAL)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2010-06
  • 1006 (Institut Pasteur)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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