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.
NCT ID: NCT03925272
Last Updated: 2022-05-17
Study Results
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Basic Information
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UNKNOWN
NA
2200 participants
INTERVENTIONAL
2011-02-02
2023-12-02
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NON_RANDOMIZED
FACTORIAL
BASIC_SCIENCE
SINGLE
Study Groups
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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 ...)
Collection of samples (blood, stool, etc.)
Genetic determinants analysis
Sample obtained after surgery performed in the context of care
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
Collection of samples (blood, stool, etc.)
Genetic determinants analysis
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
Collection of samples (blood, stool, etc.)
Genetic determinants analysis
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.
Collection of samples (blood, stool, etc.)
Genetic determinants analysis
Sample obtained after surgery performed in the context of care
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 ...
Collection of samples (blood, stool, etc.)
Genetic determinants analysis
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 ...
Collection of samples (blood, stool, etc.)
Genetic determinants analysis
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
Collection of samples (blood, stool, etc.)
Genetic determinants analysis
Interventions
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Collection of samples (blood, stool, etc.)
Genetic determinants analysis
Sample obtained after surgery performed in the context of care
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
Yes
Sponsors
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Institut Pasteur
INDUSTRY
Responsible Party
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Principal Investigators
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Marie-Noelle Ungeheuer, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Pasteur - ICAReB
Locations
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Centre médical de l'Institut Pasteur
Paris, , France
Institut Pasteur
Paris, , France
Hopital sainte Périne
Paris, , France
Hôpital Tenon
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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References
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Iglesias MC, Briceno O, Gostick E, Moris A, Meaudre C, Price DA, Ungeheuer MN, Saez-Cirion A, Mallone R, Appay V. Immunodominance of HLA-B27-restricted HIV KK10-specific CD8(+) T-cells is not related to naive precursor frequency. Immunol Lett. 2013 Jan;149(1-2):119-22. doi: 10.1016/j.imlet.2012.10.002. Epub 2012 Oct 13.
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Thomas S, Rouilly V, Patin E, Alanio C, Dubois A, Delval C, Marquier LG, Fauchoux N, Sayegrih S, Vray M, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. The Milieu Interieur study - an integrative approach for study of human immunological variance. Clin Immunol. 2015 Apr;157(2):277-93. doi: 10.1016/j.clim.2014.12.004. Epub 2015 Jan 3.
Monceaux V, Chiche-Lapierre C, Chaput C, Witko-Sarsat V, Prevost MC, Taylor CT, Ungeheuer MN, Sansonetti PJ, Marteyn BS. Anoxia and glucose supplementation preserve neutrophil viability and function. Blood. 2016 Aug 18;128(7):993-1002. doi: 10.1182/blood-2015-11-680918. Epub 2016 Jul 8.
Urrutia A, Duffy D, Rouilly V, Posseme C, Djebali R, Illanes G, Libri V, Albaud B, Gentien D, Piasecka B, Hasan M, Fontes M, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Standardized Whole-Blood Transcriptional Profiling Enables the Deconvolution of Complex Induced Immune Responses. Cell Rep. 2016 Sep 6;16(10):2777-2791. doi: 10.1016/j.celrep.2016.08.011. Epub 2016 Aug 25.
Hamimi C, David A, Versmisse P, Weiss L, Bruel T, Zucman D, Appay V, Moris A, Ungeheuer MN, Lascoux-Combe C, Barre-Sinoussi F, Muller-Trutwin M, Boufassa F, Lambotte O, Pancino G, Saez-Cirion A; ANRS CO21 CODEX cohort. Dendritic Cells from HIV Controllers Have Low Susceptibility to HIV-1 Infection In Vitro but High Capacity to Capture HIV-1 Particles. PLoS One. 2016 Aug 9;11(8):e0160251. doi: 10.1371/journal.pone.0160251. eCollection 2016.
Duffy D, Rouilly V, Braudeau C, Corbiere V, Djebali R, Ungeheuer MN, Josien R, LaBrie ST, Lantz O, Louis D, Martinez-Caceres E, Mascart F, Ruiz de Morales JG, Ottone C, Redjah L, Guen NS, Savenay A, Schmolz M, Toubert A, Albert ML; Multinational FOCIS Centers of Excellence. Standardized whole blood stimulation improves immunomonitoring of induced immune responses in multi-center study. Clin Immunol. 2017 Oct;183:325-335. doi: 10.1016/j.clim.2017.09.019. Epub 2017 Sep 22.
Piasecka B, Duffy D, Urrutia A, Quach H, Patin E, Posseme C, Bergstedt J, Charbit B, Rouilly V, MacPherson CR, Hasan M, Albaud B, Gentien D, Fellay J, Albert ML, Quintana-Murci L; Milieu Interieur Consortium. Distinctive roles of age, sex, and genetics in shaping transcriptional variation of human immune responses to microbial challenges. Proc Natl Acad Sci U S A. 2018 Jan 16;115(3):E488-E497. doi: 10.1073/pnas.1714765115. Epub 2017 Dec 27.
Patin E, Hasan M, Bergstedt J, Rouilly V, Libri V, Urrutia A, Alanio C, Scepanovic P, Hammer C, Jonsson F, Beitz B, Quach H, Lim YW, Hunkapiller J, Zepeda M, Green C, Piasecka B, Leloup C, Rogge L, Huetz F, Peguillet I, Lantz O, Fontes M, Di Santo JP, Thomas S, Fellay J, Duffy D, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Publisher Correction: Natural variation in the parameters of innate immune cells is preferentially driven by genetic factors. Nat Immunol. 2018 Jun;19(6):645. doi: 10.1038/s41590-018-0105-3.
Scepanovic P, Alanio C, Hammer C, Hodel F, Bergstedt J, Patin E, Thorball CW, Chaturvedi N, Charbit B, Abel L, Quintana-Murci L, Duffy D, Albert ML, Fellay J; Milieu Interieur Consortium. Human genetic variants and age are the strongest predictors of humoral immune responses to common pathogens and vaccines. Genome Med. 2018 Jul 27;10(1):59. doi: 10.1186/s13073-018-0568-8.
Kilens S, Meistermann D, Moreno D, Chariau C, Gaignerie A, Reignier A, Lelievre Y, Casanova M, Vallot C, Nedellec S, Flippe L, Firmin J, Song J, Charpentier E, Lammers J, Donnart A, Marec N, Deb W, Bihouee A, Le Caignec C, Pecqueur C, Redon R, Barriere P, Bourdon J, Pasque V, Soumillon M, Mikkelsen TS, Rougeulle C, Freour T, David L; Milieu Interieur Consortium. Parallel derivation of isogenic human primed and naive induced pluripotent stem cells. Nat Commun. 2018 Jan 24;9(1):360. doi: 10.1038/s41467-017-02107-w.
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Other Identifiers
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1006
Identifier Type: OTHER
Identifier Source: secondary_id
2010-06
Identifier Type: -
Identifier Source: org_study_id
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