Clinical trial NCT03421392: Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of ICT
Official title: Study of Platelets Sialylation by Flow Cytometry for the Differential Diagnosis of Immunologic and Constitutive Thrombocytopenia: Diagnostic and Prognostic Interest.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Thrombocytopenic Purpura
Keywords: constitutive thrombocytopenia
central thrombocytopenia
platelets
sialylation
flow cytometry
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assess the difference of sialylation between ITP patients and other causes of thrombocytopenia / controls
timeFrame: 18 months
Secondary outcomes:
measure: Prognostic value and therapy
timeFrame: 18 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
Study officials:
affiliation: Nantes University Hospital
name: Marc Fouassier, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.