Clinical trial NCT04056507: Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura
Official title: Retrospective Study of Splenic Immunological Markers as Predictive Factors for Response to Splenectomy in Adult Patients Affected by a Immune Thrombocytopenic Purpura
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Immune Thrombocytopenic Purpura
Splenectomy; Status
Keywords: Immunological parameters
Histological parameters
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2019-08-14
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spleens come from patients with ITP (defined as thrombocytopenia \<100 G / L) after an infectious, drug, autoimmune disease, hematological malignancy or immunodeficiency cause has been eliminated. Rodeghiero, 2009) who received a splenectomy to treat their condition in the department of Professor JL Pellegrin.

Brief summary: The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP(Immune thrombocytopenic purpura).

Detailed description: Immune thrombocytopenic purpura (ITP) is a rare autoimmune thrombocytopenia whose incidence is 2 to 5 cases / 100,000 inhabitants / year. The potentially serious haemorrhagic risk is the major issue of management. A recent international consensus conference classifies PTI according to the duration of thrombocytopenia: acute ITP (\<3 months), persistent ITP (3-12 months) and chronic ITP (\> 12 months) (Rodeghiero 2009). In the acute or persistent phase, polyvalent immunoglobulins (IVIG) and / or corticosteroids are proposed. In the chronic phase, splenectomy is a possible cure for 70% of patients. No predictor of treatment response is known.

The pathophysiology of ITP is multifactorial: platelet phagocytosis, mediated by autoantibody, macrophages of the reticuloendothelial system, and destruction in the spleen, genetic background and / or environmental factor favoring the role of certain lymphocyte subpopulations, cytotoxic or regulatory T, via their cytokine environment, abnormalities of thrombopoiesis.

At present, no predictive factor of splenectomy success has been identified. The aim of this study is to determine histological immunological parameters, sought on splenectomy pieces that may explain the failure or success of splenectomy in patients with ITP who had a splenectomy to treat their ITP.

Eligibility criteria: Inclusion Criteria:

* The analyzed spleens belong to the collection of biological samples declared to the ministry by the Laboratory of Pathology of Haut-Lévêque Hospital (Dr Parrens).

Exclusion Criteria:

* Opposition of the patient.

Primary outcomes:
measure: Complete remission (CR) after splenectomy.
timeFrame: At the inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-François VIALLARD, Pr
role: PRINCIPAL_INVESTIGATOR
References: