Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-07

Study Completion Date

2023-09-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnostic of Chronic Thrombocytopenia

NCT04071496

Congenital Thrombocytopenia Chronic Idiopathic Thrombocytopenic Purpura

COMPLETED

Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura.

NCT04070599

Immune Thrombocytopenic Purpura Autoimmune Thrombocytopenia Thrombopenia

COMPLETED PHASE3

Immunological Markers in Adult Patients With Immune Thrombocytopenic Purpura

NCT04056507

Immune Thrombocytopenic Purpura Splenectomy; Status

COMPLETED

Study of Immune Thrombocytopenia Pathogenesis:

NCT02042560

Primary Immune Thrombocytopenia (ITP)

COMPLETED

Research for Plasma Biomarkers Associated With Fatigue in Thrombocytopenic Patients

NCT06979765

Thrombopenia

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Thrombocytopenia Purpura, Thrombocytopenic Myelodysplastic Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MyeloDysplastic Syndrome

platelets \<150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features).

blood sample

Intervention Type PROCEDURE

The extra samples will be taken Blood sampling

Idiopathic Chronic Thrombocytopenia of Unknown Significance

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.

blood sample

Intervention Type PROCEDURE

The extra samples will be taken Blood sampling

Bone marrow sample

Intervention Type PROCEDURE

This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls

Immune Thrombocytopenic Purpura

Diagnosis of Immune Thrombocytopenic Purpura (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

blood sample

Intervention Type PROCEDURE

The extra samples will be taken Blood sampling

healthy volunteers undergoing cardiac surgery

patients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors

Bone marrow sample

Intervention Type PROCEDURE

This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

blood sample

The extra samples will be taken Blood sampling

Intervention Type PROCEDURE

Bone marrow sample

This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes