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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. (CoSImmGEn)

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ClinicalTrials.gov Identifier: NCT03925272
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Institut Pasteur

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 Intervention/treatment Phase
Immune System and Related Disorders Procedure: Collection of samples (blood, stool, etc.) Genetic: Genetic determinants analysis Procedure: Sample obtained after surgery performed in the context of care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 2, 2011
Estimated Primary Completion Date : December 2, 2023
Estimated Study Completion Date : December 2, 2023

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.

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)

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

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



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03925272


Contacts
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Contact: Marie-Noelle Ungeheuer, PhD +33 0140613581 marie-noelle.ungeheuer@pasteur.fr
Contact: Hélène Laude, PhD +33 0145688395 helene.laude@pasteur.fr

Locations
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France
Centre médical de l'Institut Pasteur Recruiting
Paris, France, 75015
Contact: Aude Nassif, PhD    0140613077    aude.nassif@pasteur.fr   
Contact: Maia Delage-Toriel, PhD    0145688214    maia.delage-toriel@pasteur.fr   
Institut Pasteur Recruiting
Paris, France, 75015
Contact: Marie-Noelle Ungeheuer, PhD    0140613581    marie-noelle.ungeheuer@pasteur.fr   
Contact: Hélène Laude, PhD    0145688394    helene.laude@pasteur.fr   
Hopital sainte Périne Recruiting
Paris, France, 75016
Contact: Joelle Brachat, PhD    0144963217    joelle.brachat@aphp.fr   
Principal Investigator: Dany Vythilingum, PhD         
Sponsors and Collaborators
Institut Pasteur
Investigators
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Principal Investigator: Marie-Noelle Ungeheuer, PhD Institut Pasteur - ICAReB

Publications:
Belizna C, Pregnolato F, Abad S, Alijotas-Reig J, Amital H, Amoura Z, Andreoli L, Andres E, Aouba A, Apras Bilgen S, Arnaud L, Bienvenu B, Bitsadze V, Blanco P, Blank M, Borghi MO, Caligaro A, Candrea E, Canti V, Chiche L, Chretien JM, Cohen Tervaert JW, Damian L, Delross T, Dernis E, Devreese K, Djokovic A, Esteve-Valverde E, Favaro M, Fassot C, Ferrer-Oliveras R, Godon A, Hamidou M, Hasan M, Henrion D, Imbert B, Jeandel PY, Jeannin P, Jego P, Jourde-Chiche N, Khizroeva J, Lambotte O, Landron C, Latino JO, Lazaro E, de Leeuw K, Le Gallou T, Kiliç L, Limper M, Loufrani L, Lubin R, Magy-Bertrand N, Mahe G, Makatsariya A, Martin T, Muchardt C, Nagy G, Omarjee L, Van Paasen P, Pernod G, Perrinet F, Pïres Rosa G, Pistorius MA, Ruffatti A, Said F, Saulnier P, Sene D, Sentilhes L, Shovman O, Sibilia J, Sinescu C, Stanisavljevic N, Stojanovich L, Tam LS, Tincani A, Tollis F, Udry S, Ungeheuer MN, Versini M, Cervera R, Meroni PL. HIBISCUS: Hydroxychloroquine for the secondary prevention of thrombotic and obstetrical events in primary antiphospholipid syndrome. Autoimmun Rev. 2018 Dec;17(12):1153-1168. doi: 10.1016/j.autrev.2018.05.012. Epub 2018 Oct 12. Review.

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Responsible Party: Institut Pasteur
ClinicalTrials.gov Identifier: NCT03925272    
Other Study ID Numbers: 2010-06
1006 ( Other Identifier: Institut Pasteur )
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Institut Pasteur:
immune system
environmental interactions
genetic component