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 |
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Recruitment Status :
Recruiting
First Posted : April 24, 2019
Last Update Posted : March 4, 2021
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| 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 |
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 (Clinical Trial) |
| Estimated Enrollment : | 2200 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 |
|---|---|
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
- 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.
- 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.
- 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.
- Metabolomic analysis [ Time Frame: through study completion, an average of 4 year ]Quantification of blood metabolites by mass spectrometry
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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 |
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
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
| Contact: Marie-Noelle Ungeheuer, PhD | +33 0140613581 | marie-noelle.ungeheuer@pasteur.fr | |
| Contact: Hélène Laude, PhD | +33 0145688395 | helene.laude@pasteur.fr |
| 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, MD | |
| Principal Investigator: Joelle Brachat, MD | |
| Hôpital Tenon | Not yet recruiting |
| Paris, France | |
| Contact: Michael Atlan, MD michael.atlan@aphp.fr | |
| Principal Investigator: | Marie-Noelle Ungeheuer, PhD | Institut Pasteur - ICAReB |
| 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: | March 4, 2021 |
| Last Verified: | February 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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immune system environmental interactions genetic component |