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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-A01264-41 | Other Identifier | ANSM |
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The primary objective of this study is to search for evidence of quantitative or functional defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein Purpura (HSP) as compared to a control population.
The secondary questions/objectives for this study are:
A. During an inflammatory HSP flare, is there a quantitative and / or qualitative defect in plasma Tregs? Are such blood anomalies real or are they due to a modification of the distribution of theses cells to localized sites? B. In the asymptomatic phase, are there quantitative or functional abnormalities among Tregs in subjects with HSP compared to healthy control subjects? C. Are Treg abnormalities associated with modifications in other blood cell lineages, including B cells secreting IgA and abnormally glycosylated IgA1, and secretion of cytokines during acute relapses and during the asymptomatic phase? D. Can streptococcus or other oral or digestive pathogens (bacterial or viral) (as suggested in other chronic diseases such as rheumatoid arthritis ) provoke (via stimulation Th3) isotype commutation towards secretion of IgA1 at the origin of HSP? Does HSP intestinal damage or imbalance of the intestinal microbiota allow the translocation of intestinal microorganisms that sustain this stimulation?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSP: acute episode | Patients in this group are going through an acute episode of Henoch Schönlein Purpura. Intervention: Blood samples Intervention: Stool samples |
| |
| HSP: remission | Patients in this group have had Henoch Schönlein Purpura in the past but currently have no symptoms. Intervention: Blood samples Intervention: Stool samples |
| |
| Control group | Control patients recruited from elective surgery candidates at the participating hospitals. Intervention: Blood samples Intervention: Stool samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples | Biological | Compared to routine practice, 3 additional tubes of blood will be drawn for the observational needs of this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of blood Tregs | Day 0 | |
| Absolute Treg count | number / mm^3 | Day 0 |
| Presence / absence of functional abnormality of plasma Tregs | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical abnormalities in other blood cell lines | Day 0 | |
| Serum cytokine levels | ng/ml | Day 0 |
| Serum IgA levels |
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General inclusion criteria for all sub-populations included in the study
Inclusion criteria for population A: Henoch Schönlein purpura, acute episodes
Inclusion criteria for population B: Henoch Schönlein purpura in remission
Inclusion criteria for population C: controls
Exclusion Criteria:
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Three different populations will be included in this study: (A) patients presenting with an acute episode of Henoch Schönlein purpura; (B) patients who have had an episode of Henoch Schönlein purpura in the past, but currently present with no symptoms; (C) a group of control patients recruted from elective surgery candidates at the participating hospitals.
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| Name | Affiliation | Role |
|---|---|---|
| Tu Anh Tran, MD, PhD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Montpellier - Hôpital Lapeyronie | Montpellier | 34295 | France | |||
| CHRU de Nîmes - Hôpital Universitaire Carémeau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33734346 | Result | Filleron A, Tran TA, Hubert A, Letierce A, Churlaud G, Kone-Paut I, Saadoun D, Cezar R, Corbeau P, Rosenzwajg M. Regulatory T cell/Th17 balance in the pathogenesis of paediatric Behcet disease. Rheumatology (Oxford). 2021 Dec 24;61(1):422-429. doi: 10.1093/rheumatology/keab253. |
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| ID | Term |
|---|---|
| D011695 | IgA Vasculitis |
| ID | Term |
|---|---|
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011693 | Purpura |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Stool samples: DNA extractions for microbiota analysis. Blood samples: DNA extractions for bacterial translocation analysis Blood samples: samples remaining will be kept for further analysis
| Stool samples | Biological | Stool samples will be collected for the observational needs of this study (and are not part of routine practice). |
|
mg/l |
| Day 0 |
| Presence/absence of bacterial translocation | Day 0 |
| Quantification of bacterial translocation | (10^8 copies / µl) | Day 0 |
| Number of bacterial species detected in the intestinal microbiota | Day 0 |
| Distribution of bacteria taxa present in the intestine among 3 categories | Bacteroidetes, Firmicutes and Actinobacteria | Day 0 |
| Nîmes |
| 30029 |
| France |
| D001778 |
| Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020141 | Hemostatic Disorders |
| D006474 | Hemorrhagic Disorders |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007105 | Immune Complex Diseases |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |