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NCT Number: NCT04005638

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Bordeaux - service de médecine interne

Pessac, France

Location status: Recruiting

Location contact

Carine GREIB, MD

SUB_INVESTIGATOR

Estibaliz LAZARO, Prof

SUB_INVESTIGATOR

Etienne RIVIERE, MD

SUB_INVESTIGATOR

Irene MACHELARD, MD

SUB_INVESTIGATOR

Isabelle RAYMOND, Pharm

CONTACT

[email protected]

Jean-François VIALLARD, Prof

CONTACT

jean-franç[email protected]

05.57.65.64.83 ext. +33

Jean-François VIALLARD, Prof

PRINCIPAL_INVESTIGATOR

Jean-Luc PELLEGRIN, Prof

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

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

urine sample

Biological

12 ml

Primary outcomes

  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)

Study contacts

Contact information is provided by the study sponsor or research team.

Isabelle RAYMOND, Pharm

CONTACT

[email protected]

Jean-François VIALLARD, Prof

CONTACT

jean-franç[email protected]

05.57.65.64.83 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Ministry for Health and Solidarity, France

Registry information

Acronym: BIOCAI

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Jul 2, 2019
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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