Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT

Study Overview
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Brief Summary
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Idiopathic thrombocytopenic purpura (ITP) is the most frequent auto-immune cytopenia. There is no specific biological marker and the diagnosis often results from the exclusion of other differential diagnoses, notably inherited thrombocytopenia. Recent studies have reported an original platelet destruction mechanism in ITP, by antibody-mediated desialylation of membrane proteins. The detection of platelet sialylation can be readily achieved using flow cytometry. This could provide a new biomarker of ITP, useful to ascertain a diagnosis of ITP and guide towards proper patient management.

Official Title
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Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of Immunologic and Constitutive Thrombocytopenia: Diagnostic and Prognostic Interest.

Conditions
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Idiopathic Thrombocytopenic Purpura

Intervention / Treatment
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* Other: non interventional study


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients (>18yo) with a diagnosis of ITP (primary acute, persisting or chronical) Adult patients (>18yo) with a diagnosis of non immunological thrombocytopenia (constitutive thrombocytopenia, myelodysplastic syndrome, chemotherapy-induced thrombocytopenia) Adult patients (>18 yo) without thrombocytopenia Enrolled in a Social Security system Having provided informed consent Exclusion Criteria: Minor patients (<18 yo) Enrolled in another clinical study Having received corticosteroids or polyvalent immunoglobulins in the past 4 weeks or anti-platelet therapy or NSAID during the past 7 days Having received platelet transfusion in the past fortnight With proven iron deficiency With drug-induced immune-allergic thrombocytopenia. Pregnant and breastfeeding women, guardian patients, will be excluded from this population.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Idiopathic thrombocytopenic purpura<br> | Other: non interventional study<br>* non interventional study<br>|
| non immunological thrombocytopenia<br>patient with constitutive thrombocytopenia, myelodysplastic syndrome, or chemotherapy-induced thrombocytopenia | Other: non interventional study<br>* non interventional study<br>|
| without thrombocytopenia<br> | Other: non interventional study<br>* non interventional study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls | a significant decrease in platelets sialylation in ITP patients, measured in flow cytometry with fluorescent Ricinus communis agglutinin | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prognostic value and therapy | prognostic value of the level of sialylation in ITP patients regarding disease evolution and response of first line treatments and splenectomy. | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constitutive thrombocytopenia, central thrombocytopenia, platelets, sialylation, flow cytometry