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Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia (BIOCAI)

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ClinicalTrials.gov Identifier: NCT04005638
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief Summary:
The Internal Medicine Department of Haut-Lévêque Hospital (Pr E LAZARO, Pr JL PELLEGRIN, Pr JF VIALLARD) was accredited in 2017 by the Ministry of Health as a Constitutive Reference Center for Autoimmune Cytopenia. The investigators wish to launch new research projects in autoimmune cytopenia and propose a translational and fundamental research based on collaboration between the clinical department, the biological resource center and the CNRS and INSERM research units ("Bedside to the Bench Strategy"). Thus, in the perspective of future research work, it seems imperative to set up a biological bank for the patients followed in our Reference Center.

Condition or disease Intervention/treatment
Immune Thrombocytopenia Autoimmune Hemolytic Anemia Autoimmune Neutropenia Biological: blood sample Biological: urine sample

Detailed Description:

Our department follows about 350 patients with immune thrombocytopenia (ITP), 50 with autoimmune hemolytic anemia (AHA), and about thirty patients for autoimmune neutropenia and erythroblastopenia. The number of new patients per year is about 50. The investigators are working since several years on different research topics concerning ITP and AHA.

In the field of ITP, the investigators are working on abnormalities of megakaryopoiesis present in a particular subgroup of patients. The investigators seek to identify the molecular mechanisms underlying this platelet-forming disorder. This research is done within the INSERM U1034 unit of the University of Bordeaux.

In AHA, The investigators are working on the role of regulatory CD8+ T lymphocytes and the interest of low doses of Interleukin-2 in their treatment. This part is carried out within the CNRS unit UMR 5164 ImmunoConcept. The biological collection the investigators wish to create will be available for basic research projects and may be available to the pharmaceutical industry as part of the development of new molecules.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia
Actual Study Start Date : February 2, 2019
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022


Group/Cohort Intervention/treatment
Autoimmune Cytopenia Biological: blood sample
45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Biological: urine sample
12 ml




Primary Outcome Measures :
  1. Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA) [ Time Frame: At baseline (Day 0) ]

Biospecimen Retention:   Samples With DNA
45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and urine sample


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).
Criteria

Inclusion Criteria:

  • Patients over 16 years old.
  • Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).
  • 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:

  • Positivity for HIV, Hepatitis C or B virus.
  • Pregnant or lactating woman.
  • Patient undergoing treatment for autoimmune cytopenia

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): NCT04005638


Contacts
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Contact: Jean-François VIALLARD, Prof 05.57.65.64.83 ext +33 jean-françois.viallard@chu-bordeaux.fr
Contact: Isabelle RAYMOND, Pharm isabelle.raymond@chu-bordeaux.fr

Locations
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France
CHU de Bordeaux - service de médecine interne Recruiting
Pessac, France
Contact: Jean-François VIALLARD, Prof    05.57.65.64.83 ext +33    jean-françois.viallard@chu-bordeaux.fr   
Contact: Isabelle RAYMOND, Pharm       isabelle.raymond@chu-bordeaux.fr   
Principal Investigator: Jean-François VIALLARD, Prof         
Sub-Investigator: Estibaliz LAZARO, Prof         
Sub-Investigator: Jean-Luc PELLEGRIN, Prof         
Sub-Investigator: Carine GREIB, MD         
Sub-Investigator: Irene MACHELARD, MD         
Sub-Investigator: Etienne RIVIERE, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Ministry for Health and Solidarity, France
Investigators
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Principal Investigator: Jean-François VIALLARD, Prof CHU - Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04005638    
Other Study ID Numbers: CHUBX 2018/13
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
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
Keywords provided by University Hospital, Bordeaux:
Biological collection
Additional relevant MeSH terms:
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Thrombocytopenia
Immune System Diseases
Neutropenia
Purpura, Thrombocytopenic, Idiopathic
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Blood Platelet Disorders
Hematologic Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Anemia