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 : January 27, 2022
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|Condition or disease||Intervention/treatment|
|Immune Thrombocytopenia Autoimmune Hemolytic Anemia Autoimmune Neutropenia||Biological: blood sample Biological: urine sample|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|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 :||January 2023|
|Estimated Study Completion Date :||January 2023|
Biological: blood sample
45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Biological: urine sample
- 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
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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|
- 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).
- Positivity for HIV, Hepatitis C or B virus.
- Pregnant or lactating woman.
- Patient undergoing treatment for autoimmune cytopenia
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
|Contact: Jean-François VIALLARD, Prof||05.57.65.64.83 ext +33||jean-françois.email@example.com|
|Contact: Isabelle RAYMOND, Pharmfirstname.lastname@example.org|
|CHU de Bordeaux - service de médecine interne||Recruiting|
|Contact: Jean-François VIALLARD, Prof 05.57.65.64.83 ext +33 jean-françois.email@example.com|
|Contact: Isabelle RAYMOND, Pharm firstname.lastname@example.org|
|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|
|Principal Investigator:||Jean-François VIALLARD, Prof||CHU Bordeaux|
|Responsible Party:||University Hospital, Bordeaux|
|Other Study ID Numbers:||
|First Posted:||July 2, 2019 Key Record Dates|
|Last Update Posted:||January 27, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Anemia, Hemolytic, Autoimmune
Blood Platelet Disorders
Blood Coagulation Disorders