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Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker (ICTUS)

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ClinicalTrials.gov Identifier: NCT04003220
Recruitment Status : Recruiting
First Posted : July 1, 2019
Last Update Posted : October 12, 2020
Sponsor:
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

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

Condition or disease Intervention/treatment
Thrombocytopenia Purpura, Thrombocytopenic Myelodysplastic Syndromes Procedure: blood sample Procedure: Bone marrow sample

Detailed 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)

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker
Actual Study Start Date : September 7, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021


Group/Cohort Intervention/treatment
MyeloDysplastic Syndrome
platelets <150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features).
Procedure: blood sample
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.
Procedure: blood sample
The extra samples will be taken Blood sampling

Procedure: Bone marrow sample
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
Procedure: blood sample
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
Procedure: Bone marrow sample
This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls




Primary Outcome Measures :
  1. Measure of clonality in patients with ICTUS [ Time Frame: Day 1 ]
    identification of mutations in genes known to be involved in clonal expansion


Biospecimen Retention:   Samples Without DNA

the samples for research will be taken in the department where the patient is:

  • Blood sampling: 5 ACD-A tubes (Acid Citrate Dextrose) and 2 EDTA tubes (for 30 ICTUS patients, 20 ITP patients, and 20 patients with MDS)
  • One supplementary tube of bone marrow (for 10 patients with ICTUS, and 10 Healthy controls)
  • 25 Hair bulbs (for 20 ICTUS patients)


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
In this project we will study 30 patients with ICTUS, 20 ITP with immunological features, 20 MDS patients and 10 Healthy volunteers (normal bone marrow donors, obtained during a sternotomy performed in the cardiac surgery unit).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04003220


Contacts
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Contact: Chloé JAMES, MD,PhD +335 57 65 64 78 chloe.james@chu-bordeaux.fr

Locations
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France
Immunopathologie Clinique - Hôpital Saint Louis - AP HP Recruiting
Paris, France, 75010
Contact: Lionel GALICIER, MD    +331.42.49.96.90    lionel.galicier@aphp.fr   
Principal Investigator: Lionel GALICIER, MD         
Chirurgie cardiaque - Hôpital Haut Lévêque - CHU de Bordeaux Recruiting
Pessac, France, 33600
Contact: Mathieu PERNOT, MD    +335.57.65.69.69    mathieu.pernot@chu-bordeaux.fr   
Principal Investigator: Mathieu PERNOT, MD         
Service des maladies du sang - Hôpital Haut-Lévêque - avenue de Magellan Recruiting
Pessac, France, 33600
Contact: Noel MILPIED       noel.milpied@chu-bordeaux.fr   
Sub-Investigator: Krimo BOUABDALLAH         
Sub-Investigator: Marie-Sarah DILHUYDY         
Principal Investigator: Noel MILPIED         
service de médecine interne et maladies infectieuses - Groupe hospitalier Sud Recruiting
Pessac, France
Contact: Jean-François VIALLARD, Prof       jean-francois.viallard@chu-bordeaux.fr   
Principal Investigator: Jean-François VIALLARD, Prof         
Sponsors and Collaborators
University Hospital, Bordeaux
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
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Principal Investigator: JAMES, MD, PhD University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04003220    
Other Study ID Numbers: CHUBX 2018/47
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Myelodysplastic Syndromes
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Bone Marrow Diseases
Hematologic Diseases
Blood Platelet Disorders
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Immune System Diseases