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

NCT03421392 | Completed

• 1 other identifier: RC17_0346
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Thrombocytopenic Purpura

Keywords

constitutive thrombocytopenia; central thrombocytopenia; platelets; sialylation; flow cytometry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prognostic value and therapy

  18 months

Study Arms (3)

Idiopathic thrombocytopenic purpura

Other: non interventional study

non immunological thrombocytopenia

patient with constitutive thrombocytopenia, myelodysplastic syndrome, or chemotherapy-induced thrombocytopenia

Other: non interventional study

without thrombocytopenia

Other: non interventional study

Interventions

non interventional study OTHER

non interventional study

Idiopathic thrombocytopenic purpura; non immunological thrombocytopenia; without thrombocytopenia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

3 Populations will be recruited in the study: Number of topics planned: 50 Patients in the PTI group 50 patients in the non-immunological thrombocytopenia group 50 patients in the control group

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Related 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.

  PMID: 26185093 BACKGROUND

• Sorensen 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.

  PMID: 19520807 BACKGROUND

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

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

Study Officials

• Marc Fouassier, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 5, 2018
• Study Start: January 1, 2018
• Primary Completion: October 23, 2019
• Study Completion: November 1, 2020
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)