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This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view previously untreated primary ITP patients. To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation - for each line of therapy - and the results of the biological analysis performed at each time point will then be compared.
This is a no-profit, multicenter, biological, non-pharmacologic study aimed to characterize from a biological point of view ITP patients. Patients with previously untreated primary ITP who need first-line therapy will be included in the study.
To this end, peripheral blood, fecal and bone marrow samples will be collected at baseline and at 30 days and 180 days after treatment initiation. The same assessments will be repeated in case of any potential new line of therapy.
The results of the biological analysis performed at each time point will then be compared, in order to seek changes related to the natural history of the disease, the therapy administered and the response achieved.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biological evaluation | Other | characterization of biological features of enrolled ITP patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peripheral blood and bone marrow withdrawal | Other | samples evaluation |
|
| Measure | Description | Time Frame |
|---|---|---|
| B-cell mediated disease incidence | evaluation of percentage of patients with a predominant B-cell mediated disease | at baseline |
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Inclusion Criteria:
Exclusion Criteria:
1. Secondary ITP. Patients with ANA positivity without a diagnosis of SLE are admitted to the study. As far as patients with ITP and antiphospholipid antibodies positivity, those with triple positivity (anti-beta2glicoprotein antibodies, anti-cardiolipin antibodies, lupus anticoagulans positivity) are excluded.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paola Fazi | Contact | 0670390528 | p.fazi@gimema.it | |
| Enrico Crea | Contact | 0670390514 | e.crea@gimema.it |
| Name | Affiliation | Role |
|---|---|---|
| Elisa Lucchini | SC Ematologia ASUGI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC ematologia AOU di Bologna | Recruiting | Bologna | Italy |
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| ID | Term |
|---|---|
| D016553 | Purpura, Thrombocytopenic, Idiopathic |
| ID | Term |
|---|---|
| D011696 | Purpura, Thrombocytopenic |
| D011693 | Purpura |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
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| Ematologia e centro trapianti ASL Piacenza | Recruiting | Piacenza | Italy |
|
| Ematologia Policlinico Universitario A.Gemelli | Recruiting | Roma | Italy |
|
| Sc Ematologia Ospedale S.G. Battista Molinette - Università Degli Studi Di Torino | Recruiting | Torino | Italy |
|
| SC Ematologia ASUGI | Recruiting | Trieste | Italy |
|
| D006425 |
| Hemic and Lymphatic Diseases |
| D057049 | Thrombotic Microangiopathies |
| D013921 | Thrombocytopenia |
| D001791 | Blood Platelet Disorders |
| D000095542 | Cytopenia |
| D006474 | Hemorrhagic Disorders |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |