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

NCT ID: NCT03421392

Last Updated: 2022-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2020-11-01

Brief Summary

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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

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Conditions

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Idiopathic Thrombocytopenic Purpura

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Idiopathic thrombocytopenic purpura

non interventional study

Intervention Type OTHER

non interventional study

non immunological thrombocytopenia

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

non interventional study

Intervention Type OTHER

non interventional study

without thrombocytopenia

non interventional study

Intervention Type OTHER

non interventional study

Interventions

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non interventional study

non interventional study

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fouassier, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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Nantes University Hospital

Nantes, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 26185093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19520807 (View on PubMed)

Other Identifiers

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RC17_0346

Identifier Type: -

Identifier Source: org_study_id

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