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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04005638
Acronym
BIOCAI
Enrollment
200
Registered
2019-07-02
Start date
2019-02-02
Completion date
2027-01-31
Last updated
2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Hemolytic Anemia, Autoimmune Neutropenia, Immune Thrombocytopenia

Keywords

Biological collection

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.

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.

Interventions

BIOLOGICALblood sample

45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

BIOLOGICALurine sample

12 ml

Sponsors

Ministry for Health and Solidarity, France
CollaboratorOTHER_GOV
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA)At baseline (Day 0)

Countries

France

Contacts

Primary ContactJean-François VIALLARD, Prof
jean-françois.viallard@chu-bordeaux.fr05.57.65.64.83
Backup ContactIsabelle RAYMOND, Pharm
isabelle.raymond@chu-bordeaux.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026