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

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.

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Key information

Conditions

Idiopathic Thrombocytopenic Purpura Autoimmune Diseases Blood Coagulation Disorders Blood Platelet Disorders Cytopenia Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Purpura, Thrombocytopenic Purpura, Thrombocytopenic, Idiopathic Signs and Symptoms Skin Manifestations Thrombocytopenia Thrombotic Microangiopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, 44093, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non interventional study

Other

non interventional study

Primary outcomes

Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls

Time frame: 18 months

a significant decrease in platelets sialylation in ITP patients, measured in flow cytometry with fluorescent Ricinus communis agglutinin

Secondary outcomes

Prognostic value and therapy

Time frame: 18 months

prognostic value of the level of sialylation in ITP patients regarding disease evolution and response of first line treatments and splenectomy.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: SYMPATHIC

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2020
First posted: Feb 5, 2018
Registry last updated: Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed