Condition or disease | Intervention/treatment |
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Thrombocytopenia Purpura, Thrombocytopenic Myelodysplastic Syndromes | Procedure: blood sample Procedure: Bone marrow sample |
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 |
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MyeloDysplastic Syndrome
platelets <150 G/l and diagnosis of myelodysplasia according to the WHO classification (abnormal bone marrow features).
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Procedure: blood sample
The extra samples will be taken Blood sampling
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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.
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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
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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
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Procedure: blood sample
The extra samples will be taken Blood sampling
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healthy volunteers undergoing cardiac surgery
patients with normal blood counts undergoing cardiovascular surgery for valve replacement, or healthy bone-marrow donors
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Procedure: Bone marrow sample
This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls
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the samples for research will be taken in the department where the patient is:
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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chloé JAMES, MD,PhD | +335 57 65 64 78 | chloe.james@chu-bordeaux.fr |
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 |
Principal Investigator: | JAMES, MD, PhD | University Hospital, Bordeaux |
Tracking Information | |||||
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First Submitted Date | June 26, 2019 | ||||
First Posted Date | July 1, 2019 | ||||
Last Update Posted Date | October 12, 2020 | ||||
Actual Study Start Date | September 7, 2020 | ||||
Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures |
Measure of clonality in patients with ICTUS [ Time Frame: Day 1 ] identification of mutations in genes known to be involved in clonal expansion
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Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures | Not Provided | ||||
Original Secondary Outcome Measures | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title | Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker | ||||
Official Title | Idiopathic Chronic Thrombocytopenia of Undetermined Significance : Pathogenesis and Biomarker | ||||
Brief Summary | It is a translational research study with mechanistical objectives and including biological samples of patients with thrombocytopenia | ||||
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) | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description:
the samples for research will be taken in the department where the patient is:
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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). | ||||
Condition |
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Intervention |
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Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
80 | ||||
Original Estimated Enrollment | Same as current | ||||
Estimated Study Completion Date | September 1, 2021 | ||||
Estimated Primary Completion Date | September 1, 2021 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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Listed Location Countries | France | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT04003220 | ||||
Other Study ID Numbers | CHUBX 2018/47 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement |
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Responsible Party | University Hospital, Bordeaux | ||||
Study Sponsor | University Hospital, Bordeaux | ||||
Collaborators | Institut National de la Santé Et de la Recherche Médicale, France | ||||
Investigators |
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PRS Account | University Hospital, Bordeaux | ||||
Verification Date | October 2020 |