SYMPATHIC: Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Idiopathic thrombocytopenic purpura
|
Other: non interventional study
non interventional study
|
| non immunological thrombocytopenia patient with constitutive thrombocytopenia, myelodysplastic syndrome, or chemotherapy-induced thrombocytopenia |
Other: non interventional study
non interventional study
|
| without thrombocytopenia
|
Other: non interventional study
non interventional study
|
Outcome Measures
Primary Outcome Measures
- Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls [18 months]
a significant decrease in platelets sialylation in ITP patients, measured in flow cytometry with fluorescent Ricinus communis agglutinin
Secondary Outcome Measures
- Prognostic value and therapy [18 months]
prognostic value of the level of sialylation in ITP patients regarding disease evolution and response of first line treatments and splenectomy.
Eligibility Criteria
Criteria
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
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Enrolled in a Social Security system
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Having provided informed consent
Exclusion Criteria:
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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
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Having received platelet transfusion in the past fortnight
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With proven iron deficiency
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With drug-induced immune-allergic thrombocytopenia.
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Pregnant and breastfeeding women,
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guardian patients, will be excluded from this population.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nantes University Hospital | Nantes | France | 44093 |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
- Principal Investigator: Marc Fouassier, Dr, Nantes University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Li J, van der Wal DE, Zhu G, Xu M, Yougbare I, Ma L, Vadasz B, Carrim N, Grozovsky R, Ruan M, Zhu L, Zeng Q, Tao L, Zhai ZM, Peng J, Hou M, Leytin V, Freedman J, Hoffmeister KM, Ni H. Desialylation is a mechanism of Fc-independent platelet clearance and a therapeutic target in immune thrombocytopenia. Nat Commun. 2015 Jul 17;6:7737. doi: 10.1038/ncomms8737.
- Sørensen AL, Rumjantseva V, Nayeb-Hashemi S, Clausen H, Hartwig JH, Wandall HH, Hoffmeister KM. Role of sialic acid for platelet life span: exposure of beta-galactose results in the rapid clearance of platelets from the circulation by asialoglycoprotein receptor-expressing liver macrophages and hepatocytes. Blood. 2009 Aug 20;114(8):1645-54. doi: 10.1182/blood-2009-01-199414. Epub 2009 Jun 11.
- RC17_0346