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.
- Conditions
- Immune System and Related Disorders
- Interventions
- Procedure: Collection of samples (blood, stool, etc.)Genetic: Genetic determinants analysisProcedure: Sample obtained after surgery performed in the context of care
- Registration Number
- NCT03925272
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 2200
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Patients with Suppurated Hidradenitis Collection of samples (blood, stool, etc.) 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 ...) Patients with chronic inflammatory diseases (SPA, Crohn, ...) Genetic determinants analysis 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. Patients with chronic inflammatory diseases (SPA, Crohn, ...) Sample obtained after surgery performed in the context of care 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. Healthy cases relatives Genetic determinants analysis 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 ... Subjects vaccinated against COVID-19 Genetic determinants analysis 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 Patients with Alzheimer disease Genetic determinants analysis 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 Healthy cases Collection of samples (blood, stool, etc.) 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 ... Subjects vaccinated against COVID-19 Collection of samples (blood, stool, etc.) 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 Healthy cases Genetic determinants analysis 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 ... Patients with Suppurated Hidradenitis Genetic determinants analysis 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 ...) Patients with familial adenomatous polyposis Collection of samples (blood, stool, etc.) 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 Patients with familial adenomatous polyposis Genetic determinants analysis 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 Patients with Suppurated Hidradenitis Sample obtained after surgery performed in the context of care 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 ...) Patients with Alzheimer disease Collection of samples (blood, stool, etc.) 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 Patients with chronic inflammatory diseases (SPA, Crohn, ...) Collection of samples (blood, stool, etc.) 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. Healthy cases relatives Collection of samples (blood, stool, etc.) 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 ...
- Primary Outcome Measures
Name Time Method Immunological analysis 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
Name Time Method Microbiota analysis 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 through study completion, an average of 4 year Quantification of blood metabolites by mass spectrometry
Genetic analysis 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.
Trial Locations
- Locations (4)
Hopital sainte Périne
🇫🇷Paris, France
Centre médical de l'Institut Pasteur
🇫🇷Paris, France
Hôpital Tenon
🇫🇷Paris, France
Institut Pasteur
🇫🇷Paris, France