Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker

Myelodysplastic Syndromes Clinical Trial

— ICTUS  

Official title:

Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04003220
• Other study ID #: CHUBX 2018/47
• Status: Recruiting
• Start date: September 7, 2020
• Est. completion date: September 7, 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Bordeaux
• Contact: Chloé JAMES, MD,PhD
• Phone: +335 57 65 64 78
• Email: chloe.james[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia

Description:

This study is a prospective study to collect blood, bone marrow and hair bulb from patients with thrombocytopenia, to better understand the mechanism of idiopathic chronic thrombocytopenia of undetermined significance (ICTUS)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: September 7, 2023
• Est. primary completion date: September 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Myelodysplastic Syndromes
• Purpura
• Purpura, Thrombocytopenic
• Thrombocytopenia

Intervention

Procedure:
• blood sample
The extra samples will be taken Blood sampling
• Bone marrow sample
This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls

Locations

Country	Name	City	State
France	Immunopathologie Clinique - Hôpital Saint Louis - AP HP	Paris
France	Chirurgie cardiaque - Hôpital Haut Lévêque - CHU de Bordeaux	Pessac
France	service de médecine interne et maladies infectieuses - Groupe hospitalier Sud	Pessac
France	Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of clonality in patients with ICTUS	identification of mutations in genes known to be involved in clonal expansion	Day 1