Informations générales (source: ClinicalTrials.gov)
Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker (ICTUS)
Observational
University Hospital, Bordeaux (Voir sur ClinicalTrials)
septembre 2020
septembre 2023
02 novembre 2024
It is a translational research study with mechanistical objectives and including
biological samples of patients with thrombocytopenia
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Chirurgie cardiaque - Hôpital Haut Lévêque - CHU de Bordeaux - 33600 - Pessac - France | Mathieu PERNOT, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Immunopathologie Clinique - Hôpital Saint Louis - AP HP - 75010 - Paris - France | Lionel GALICIER, MD | Contact (sur clinicalTrials) | |||
| service de médecine interne et maladies infectieuses - Groupe hospitalier Sud - Pessac - France | Jean-François VIALLARD, Prof | Contact (sur clinicalTrials) | |||
| Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan - 33600 - Pessac - France | Noel MILPIED | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Age: 18-80
- Nosological criteria for thrombocytopenic patients:
- ICTUS: acquired thrombocytopenia lasting>6 months, without feature of dysimmunity
(antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab,
cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia
in the family. All ICTUS patients included in the study will thus have a bone marrow
aspiration.
- ITP: Diagnosis of ITP is made according to the international ITP consensus
(diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive
diagnosis of ITP is made when the history, physical examination, complete blood
count, and examination of the peripheral blood smears do not suggest other
etiologies for the thrombocytopenia. There is no "gold standard" test that can
reliably establish the diagnosis. We are concerned that this group of patients may
include ICTUS patients.
- ITP with immunological features: ITP with detectable anti-platelet antibodies (Ab)
and/or autoimmunity (anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab,
cryoglobulinemia), and/or previously responsive to immunomodulatory ITP-directed
therapies (steroids, intravenous Immunoglobulin, rituximab, splenectomy). We will
use these patients as non-ICTUS, ITP positive controls.
- Thrombocytopenic myelodysplasia: platelets <150 G/l and diagnosis of myelodysplasia
according to the WHO classification (abnormal bone marrow features).
- Healthy controls: patients with normal blood counts undergoing cardiovascular
surgery for valve replacement, or healthy bone-marrow donors.
- Affiliated person or beneficiary of a social security scheme. Free, informed and
written consent signed by the participant and the investigator (at the latest on the
day of inclusion and before any examination required by the research).
- Age: 18-80
- Nosological criteria for thrombocytopenic patients:
- ICTUS: acquired thrombocytopenia lasting>6 months, without feature of dysimmunity
(antiplatelet Ab, or anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab,
cryoglobulinemia), normal bone marrow examination, absence of other thrombocytopenia
in the family. All ICTUS patients included in the study will thus have a bone marrow
aspiration.
- ITP: Diagnosis of ITP is made according to the international ITP consensus
(diagnostic criteria of Rodeghiero){Provan, 2010 #18}, knowing that a presumptive
diagnosis of ITP is made when the history, physical examination, complete blood
count, and examination of the peripheral blood smears do not suggest other
etiologies for the thrombocytopenia. There is no "gold standard" test that can
reliably establish the diagnosis. We are concerned that this group of patients may
include ICTUS patients.
- ITP with immunological features: ITP with detectable anti-platelet antibodies (Ab)
and/or autoimmunity (anti nuclear Ab, anti ENA Ab, ANCA, anti-CCP Ab,
cryoglobulinemia), and/or previously responsive to immunomodulatory ITP-directed
therapies (steroids, intravenous Immunoglobulin, rituximab, splenectomy). We will
use these patients as non-ICTUS, ITP positive controls.
- Thrombocytopenic myelodysplasia: platelets <150 G/l and diagnosis of myelodysplasia
according to the WHO classification (abnormal bone marrow features).
- Healthy controls: patients with normal blood counts undergoing cardiovascular
surgery for valve replacement, or healthy bone-marrow donors.
- Affiliated person or beneficiary of a social security scheme. Free, informed and
written consent signed by the participant and the investigator (at the latest on the
day of inclusion and before any examination required by the research).
- Age under 18 or over 80
- Persons placed under judicial protection,
- Persons participating in another research including a period of exclusion still in
course
- Persons in emergency situation,
- Pregnant or nursing women,
- Women of childbearing age who do not benefit from effective contraception (HAS
criteria),
- Brain death or deceased persons,
- Person who doesn't speak French, doesn't read it, doesn't write it, and doesn't have
a schooling in France.