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

Completed

• Conditions: Idiopathic Thrombocytopenic Purpura
• Interventions: Other: non interventional study

• Registration Number: NCT03421392
• Lead Sponsor: Nantes University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-01-29
• Study First Posted: 2018-02-05
• Primary Completion: 2019-10-23
• Study Completion: 2020-11-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-17
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Idiopathic thrombocytopenic purpura	non interventional study	-
non immunological thrombocytopenia	non interventional study	patient with constitutive thrombocytopenia, myelodysplastic syndrome, or chemotherapy-induced thrombocytopenia
without thrombocytopenia	non interventional study	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Nantes University Hospital; 🇫🇷 Nantes, France