Healthy VolunteersPRIERRNCT01715623
Polymorphism of the IgH Locus Regulatory Region as a Prognostic Factor During Immune Pathologies.
An observational study of Healthy Volunteers and Children With HSP, run by University Hospital, Limoges at 4 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Children With HSP, Subject With Allergy
- What is being tested?
- a blood sample
- How many people
- 486 participants
- Where
- 4 sitesFrance
- Study dates
- Oct 2012to 16 Dec 2014
- Phase
- Observational
- 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 4 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 4 populations : * Healthy Volunteers * subjects with HPS * subjects with peanut allergy or hymenoptera venom allergy * lymphoma (biological collection)
Who may be able to join
- 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:
Show all 9Show fewer
- 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,
Who cannot join
- subject with allergy or subject with Henoch Schonlein Purpura(HSP): known pregnancy patient under guardianship
- Healthy Volunteers:
- Allergy known pregnancy patient under guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
Clinical Investigation Center
Limoges, 87042
Nephrology
Limoges, 87042
Pediatric
Limoges, 87042
Pneumology
Limoges, 87042
About this study
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…).
Read more
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).
Read the detailed description
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?
- Conditions
- Healthy Volunteers, Children With HSP, Subject With Allergy, Lymphoma
- Being tested
- a blood sample
- Keywords
- polymorphism, serum Ig
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
a blood sampleBiological
Dosage of Ig
| Study group | Role | What they receive |
|---|---|---|
| Children with HSP | children with Purpura of Henoch-Schönlein with or without renal complication Receives: Biological: a blood sample | |
| healthy volunteers | healthy volunteers without allergy Receives: Biological: a blood sample | |
| subjects with allergy | subjects with peanut allergy or hymenoptera venom allergy Receives: Biological: a blood sample | |
| lymphoma | lymphoma-proliferation with chromosome 14 translocation Receives: Biological: a blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
the percentage of allele B
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)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013
- Study completion16 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Direction Générale de la Santé, France
- Responsible party
- Sponsor
- Investigators
- Michel COGNE, MD, Principal investigator, Limoges UH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715623
- Sponsor's protocol ID
- I12002 PRIERR
- Acronym
- PRIERR
- Status last verified
- Jan 2019
- First submitted
- 22 Oct 2012
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polymorphism of the IgH Locus Regulatory Region as a Prognostic Factor During Immune Pathologies.
- ClinicalTrials.gov ID
- NCT01715623
- Acronym / sponsor ID
- PRIERR / I12002 PRIERR
- Conditions
- Healthy Volunteers, Children With HSP, Subject With Allergy, Lymphoma
- Keywords
- polymorphism, serum Ig
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France, Direction Générale de la Santé, France
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- 16 Dec 2014 (actual)
- First posted
- 29 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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?
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Children with HSP | – | Biological: a blood samplechildren with Purpura of Henoch-Schönlein with or without renal complication |
| healthy volunteers | – | Biological: a blood samplehealthy volunteers without allergy |
| subjects with allergy | – | Biological: a blood samplesubjects with peanut allergy or hymenoptera venom allergy |
| lymphoma | – | Biological: a blood samplelymphoma-proliferation with chromosome 14 translocation |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 4 populations : * Healthy Volunteers * subjects with HPS * subjects with peanut allergy or hymenoptera venom allergy * lymphoma (biological collection)
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (3 listed)
- subject with allergy or subject with Henoch Schonlein Purpura(HSP): known pregnancy patient under guardianship
- Healthy Volunteers:
- Allergy known pregnancy patient under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| a blood sampleDosage of Ig | Biological | Children with HSP, healthy volunteers, lymphoma, subjects with allergy |
Primary outcome
the percentage of allele B
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel COGNE, MD principal investigator
Limoges UH
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers and Children With HSP, run by University Hospital, Limoges 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 9 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the percentage of allele B (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2019.