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Polymorphism of the IgH Locus Regulatory Region as a Prognostic Factor During Immune Pathologies. (PRIERR)

18 januari 2019 uppdaterad av: University Hospital, Limoges

The investigators previously showed that both antibody class switching (from IgM to IgG, IgA or IgE) and antibody secretion are controlled by a polymorphic "3' regulatory region" (3'RR) of the immunoglobulin heavy chain (IgH) locus. Alleles of the 3'RR have shown influences on the severity and progression of IgA nephropathy (IgAN) (with an over-representation of the B allele among patients with severe kidney IgA deposits). Allele B also constitutes a risk factor for celiac disease, herpetiform dermatitis, psoriasis and rheumatoid arthritis. Since the 3'RR now appears as a crucial regulator of Ig production, we wish to check whether its genetic polymorphism might influence not only the occurrence of immunopathologic processes involving class-switched antibody deregulated production but also the severity of such diseases or the time course of their progression. We wish to focus on two conditions involving class-switched antibodies: on one hand the severe forms of IgE hypersensitivities, and on the other hand a disease involving pathogenic IgA and for which the prognosis is currently very difficult to predict at the onset of the disease: Henoch-Schonlein purpura (HSP).

Regarding hypersensitivities, the diversity of their clinical manifestations prompt us to focus on homogeneous groups of patients and we thus wish to concentrate on two groups of patients who are frequently referred to the hospital: severe allergies to Hymenoptera venoms and severe food allergies related to peanut allergens sensitization. These groups will be built by considering multiple clinical criteria (clinical history, severity of the manifestations, positive skin tests, and positive oral provocation tests for peanut allergens…) and biological criteria authenticating the mechanisms of the disease (high specific serum IgE, demonstration of specific basophil activation by the allergen…).

In parallel to the study in patients, we will include a large cohort of healthy controls (400 individuals), in order to be able to decipher whether correlations can be seen between:

  • IgH 3'RR genotypes
  • The serum accumulation of the various Ig classes, including IgG subclasses, IgA (which are sometimes depicted as protective, sometimes as tolerogenic and anti-inflammatory) and IgE (highly pro-inflammatory and responsible for hypersensitivities)
  • IgG allotypes (with 6 frequent IgG haplotypes known in human and previously reported as correlated with varying levels of IgG and IgE production in normal individuals).

Studieöversikt

Detaljerad beskrivning

This study should thus finally provide answers to 5 questions which are currently un-addressed:

  • How the 3'RR alleles are linked to IgG allotypes and corresponding IgH haplotypes?
  • Is there a physiological link between 3'RR alleles and production of the various Ig classes and sub-classes?
  • Is the 3'RR polymorphism connected with the risk of more severe forms of allergic diseases?
  • Is the 3'RR polymorphism connected with the risk of occurrence and/or severe evolution of HSP?
  • Is the oncogenicity of translocations affecting the IgH locus connected to the strength of the 3'RR allelic variants?

Studietyp

Observationell

Inskrivning (Faktisk)

486

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Limoges, Frankrike, 87042
        • Clinical Investigation Center
      • Limoges, Frankrike, 87042
        • Nephrology
      • Limoges, Frankrike, 87042
        • Pediatric
      • Limoges, Frankrike, 87042
        • Pneumology

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

4 år och äldre (Barn, Vuxen, Äldre vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

4 populations :

  • Healthy Volunteers
  • subjects with HPS
  • subjects with peanut allergy or hymenoptera venom allergy
  • lymphoma (biological collection)

Beskrivning

Inclusion Criteria:

  • Healthy Volunteers:

Age ≥ 18 and < 50 years No history of allergy, haematological malignancies or immune diseases

  • Subjects with allergy:
  • Children:

Age ≥ 4 and < 18 years Clinical history supporting the diagnosis of severe food allergy Peanut specific IgE (Arah2) -Adults: Age > 18 and < 60 years History of severe reaction after antigenic challenge Anaphylactic shock already experienced Specific IgE or positive BAT Positive prick tests

  • subject with HPS:
  • Children:

Age ≥ 4 and < 18 years Henoch Schonlein Purpura (HSP) documented by Ankara 2008 criteria

-Adult: Henoch Schonlein Purpura(HSP) with renal involvement Adults ≥ 18 years,

Exclusion Criteria:

  • subject with allergy or subject with Henoch Schonlein Purpura(HSP): known pregnancy patient under guardianship
  • Healthy Volunteers:

Allergy known pregnancy patient under guardianship

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Children with HSP
children with Purpura of Henoch-Schönlein with or without renal complication
Dosage of Ig
healthy volunteers
healthy volunteers without allergy
Dosage of Ig
subjects with allergy
subjects with peanut allergy or hymenoptera venom allergy
Dosage of Ig
lymphoma
lymphoma-proliferation with chromosome 14 translocation
Dosage of Ig

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
the percentage of allele B
Tidsram: one day
A comparison will be made of the percentage of allele B between healthy volunteers and the three cohorts of subjects with various diseases: (1) lymphoma (lymphoma-proliferation with chromosome 14 translocation ), (2) Henoch-Schonlein purpura HSP (3), allergy (peanut and Hymenoptera venom)
one day

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 oktober 2012

Primärt slutförande (Faktisk)

1 april 2013

Avslutad studie (Faktisk)

16 december 2014

Studieregistreringsdatum

Först inskickad

22 oktober 2012

Först inskickad som uppfyllde QC-kriterierna

24 oktober 2012

Första postat (Uppskatta)

29 oktober 2012

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 januari 2019

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 januari 2019

Senast verifierad

1 januari 2019

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • I12002 PRIERR

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