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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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.

Clinicaltrials.gov identifier NCT03925272

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted June 7, 2019

Study Description

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.

  • Condition or Disease:Immune System and Related Disorders
  • Intervention/Treatment: Procedure: Collection of samples (blood, stool, etc.)
    Genetic: Genetic determinants analysis
    Procedure: Sample obtained after surgery performed in the context of care
  • Phase: N/A
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. 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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 800 participants
  • Allocation: Non-Randomized
  • Intervention Model: Factorial Assignment
  • Masking: Single (Participant)
  • Primary Purpose: Basic Science
  • 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"
  • Actual Study Start Date: February 2011
  • Estimated Primary Completion Date: December 2023
  • Estimated Study Completion Date: December 2023
Arms and interventions
Arm Intervention/treatment
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 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 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: Patients with Alzheimer disease
Human biological samples : stool, blood (20 ml) 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 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. 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 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: 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
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. Metabolomic analysis [ Time Frame: through study completion, an average of 4 year ]
    Quantification of blood metabolites by mass spectrometry
Eligibility Criteria
  • Ages Eligible for Study: 18 to 100 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts

Contact: Marie-Noelle Ungeheuer, PhD +33 0140613581 marie-noelle.ungeheuer@pasteur.fr

Contact: Hélène Laude, PhD +33 0145688395 helene.laude@pasteur.fr

Locations

France
Centre médical de l'Institut Pasteur
Paris

France
Institut Pasteur
Paris

France
Hopital sainte Périne
Paris

Sponsors and Collaborators

Institut Pasteur

Investigators

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

More Information