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Immune System and Related DisordersCoSImmGEnNCT03925272

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.

A study testing Collection of samples (blood, stool, etc.), Genetic determinants analysis and Sample obtained after surgery performed in the context of care in people with Immune System and Related Disorders, run by Institut Pasteur at 4 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Immune System and Related Disorders
What is being tested?
Collection of samples (blood, stool, etc.), Genetic determinants analysis and Sample obtained after surgery performed in the context of care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,200 participants
Where
4 sitesFrance
Study dates
2 Feb 2011to 2 Dec 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

4 sites in 1 country.

Marie-Noelle Ungeheuer, PhD contact

+33 0140613581

marie-noelle.ungeheuer@pasteur.fr

Hélène Laude, PhD contact

+33 0145688395

helene.laude@pasteur.fr

France4 sites, 4 recruiting

  • Centre médical de l'Institut Pasteur

    Paris, 75015

    Aude Nassif, PhD, 0140613077, aude.nassif@pasteur.fr

    Maia Delage-Toriel, PhD, 0145688214, maia.delage-toriel@pasteur.fr

    Recruiting

  • Institut Pasteur

    Paris, 75015

    Marie-Noelle Ungeheuer, PhD, 0140613581, marie-noelle.ungeheuer@pasteur.fr

    Hélène Laude, PhD, 0145688394, helene.laude@pasteur.fr

    Recruiting

  • Hopital sainte Périne

    Paris, 75016

    Joelle Brachat, PhD, 0144963217, joelle.brachat@aphp.fr

    Dany Vythilingum, MD

    Recruiting

  • Hôpital Tenon

    Paris

    Michael Atlan, MD, michael.atlan@aphp.fr

    Not yet recruiting

Other trials in France

About this study

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"

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.

Read the 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.

Being tested
Collection of samples (blood, stool, etc.), Genetic determinants analysis, Sample obtained after surgery performed in the context of care
Keywords
immune system, environmental interactions, genetic component

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collection of samples (blood, stool, etc.)Procedure or surgery

  • Genetic determinants analysisGenetic

  • Sample obtained after surgery performed in the context of careProcedure or surgery

Study groups in NCT03925272
Study groupRoleWhat they receive
Patients with Suppurated HidradenitisExperimentalHuman 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 ...)
Receives: Procedure: Collection of samples (blood, stool, etc.); Genetic: Genetic determinants analysis; Procedure: Sample obtained after surgery performed in the context of care
Patients with Alzheimer diseaseExperimentalHuman 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
Receives: Procedure: Collection of samples (blood, stool, etc.); Genetic: Genetic determinants analysis
Patients with familial adenomatous polyposisExperimentalHuman 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
Receives: Procedure: Collection of samples (blood, stool, etc.); Genetic: Genetic determinants analysis
Patients with chronic inflammatory diseases (SPA, Crohn, ...)ExperimentalHuman 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.
Receives: Procedure: Collection of samples (blood, stool, etc.); Genetic: Genetic determinants analysis; Procedure: Sample obtained after surgery performed in the context of care
Healthy casesExperimentalHuman 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 ...
Receives: Procedure: Collection of samples (blood, stool, etc.); Genetic: Genetic determinants analysis
Healthy cases relativesExperimentalHuman 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 ...
Receives: Procedure: Collection of samples (blood, stool, etc.); Genetic: Genetic determinants analysis
Subjects vaccinated against COVID-19ExperimentalHuman 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
Receives: Procedure: Collection of samples (blood, stool, etc.); Genetic: Genetic determinants analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunological analysis

    Percentage of blood cells harbouring morphological of functional abnormalities identified by flow cytometry and TrueCulture system analysis.

    Measured: through study completion, an average of 4 year

Secondary outcomes (3)

  1. Genetic analysis

    Identification of genetic factors implicated in or predisposing to specific diseases through gene expression quantification, targeted genotyping of exome sequencing or whole genome sequencing.

    Measured: through study completion, an average of 4 year

  2. Microbiota analysis

    Identification of specific compositions of intestinal and/or cutaneous microbiota associated with specific diseases by metagenomic analysis.

    Measured: through study completion, an average of 4 year

  3. Metabolomic analysis

    Quantification of blood metabolites by mass spectrometry

    Measured: through study completion, an average of 4 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2019
  2. Study start2 Feb 2011
  3. Primary completion2 Dec 2023 (estimated)
  4. Study completion2 Dec 2023 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Factorial
Masking
Single blind
Who is masked
Participant
Enrolment
2,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03925272
Sponsor's protocol ID
2010-06
Other IDs
1006
Acronym
CoSImmGEn
Status last verified
May 2022
First submitted
9 Apr 2019
Last updated
17 May 2022
Results posted
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23068784

  • Duffy D, Rouilly V, Libri V, Hasan M, Beitz B, David M, Urrutia A, Bisiaux A, Labrie ST, Dubois A, Boneca IG, Delval C, Thomas S, Rogge L, Schmolz M, Quintana-Murci L, Albert ML; Milieu Interieur Consortium. Functional analysis via standardized whole-blood stimulation systems defines the boundaries of a healthy immune response to complex stimuli. Immunity. 2014 Mar 20;40(3):436-50. doi: 10.1016/j.immuni.2014.03.002.

    PubMed 24656047

  • 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.

    PubMed 25562703

  • 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.

    PubMed 27402974

  • 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.

    PubMed 27568558

  • 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.

    PubMed 27505169

  • 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.

    PubMed 28943400

  • 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.

    PubMed 29282317

  • 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.

    PubMed 29725081

  • 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.

    PubMed 30053915

  • 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.

    PubMed 29367672

  • Belizna C, Stojanovich L, Cohen-Tervaert JW, Fassot C, Henrion D, Loufrani L, Nagy G, Muchardt C, Hasan M, Ungeheuer MN, Arnaud L, Alijotas-Reig J, Esteve-Valverde E, Nicoletti F, Saulnier P, Godon A, Reynier P, Chretien JM, Damian L, Omarjee L, Mahe G, Pistorius MA, Meroni PL, Devreese K. Primary antiphospholipid syndrome and antiphospholipid syndrome associated to systemic lupus: Are they different entities? Autoimmun Rev. 2018 Aug;17(8):739-745. doi: 10.1016/j.autrev.2018.01.027. Epub 2018 Jun 6.

    PubMed 29885541

  • 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, Kilic 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, Pires 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.

    PubMed 30316994

  • Prigent J, Lorin V, Kok A, Hieu T, Bourgeau S, Mouquet H. Scarcity of autoreactive human blood IgA+ memory B cells. Eur J Immunol. 2016 Oct;46(10):2340-2351. doi: 10.1002/eji.201646446. Epub 2016 Aug 25.

    PubMed 27469325

  • Bouchet J, Del Rio-Iniguez I, Vazquez-Chavez E, Lasserre R, Aguera-Gonzalez S, Cuche C, McCaffrey MW, Di Bartolo V, Alcover A. Rab11-FIP3 Regulation of Lck Endosomal Traffic Controls TCR Signal Transduction. J Immunol. 2017 Apr 1;198(7):2967-2978. doi: 10.4049/jimmunol.1600671. Epub 2017 Feb 24.

    PubMed 28235866

Questions about this trial

What is this clinical trial studying?

A study testing Collection of samples (blood, stool, etc.), Genetic determinants analysis and Sample obtained after surgery performed in the context of care in people with Immune System and Related Disorders, run by Institut Pasteur at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marie-Noelle Ungeheuer, PhD (+33 0140613581, marie-noelle.ungeheuer@pasteur.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunological analysis (time frame: through study completion, an average of 4 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03925272, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.

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