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

Idiopathic Thrombocytopenic Purpura Clinical Trial

— SYMPATHIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03421392
• Other study ID #: RC17_0346
• Status: Completed
• Start date: January 1, 2018
• Est. completion date: November 1, 2020

Study information

• Verified date: January 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: November 1, 2020
• Est. primary completion date: October 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Other:
• non interventional study
non interventional study

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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