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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03421392

Acronym

SYMPATHIC

Enrollment

Registered

2018-02-05

Start date

2018-01-01

Completion date

2020-11-01

Last updated

2022-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

constitutive thrombocytopenia, central thrombocytopenia, platelets, sialylation, flow cytometry

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.

Interventions

OTHERnon interventional study

non interventional study

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026