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

Immune Thrombocytopenia Clinical Trial

— BIOCAI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005638
• Other study ID #: CHUBX 2018/13
• Status: Recruiting
• Start date: February 2, 2019
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Bordeaux
• Contact: Jean-François VIALLARD, Prof
• Phone: 05.57.65.64.83
• Email: jean-françois.viallard[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Autoimmune Hemolytic Anemia
• Autoimmune Neutropenia
• Immune Thrombocytopenia
• Neutropenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

Biological:
• blood sample
45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
• urine sample
12 ml

Locations

Country	Name	City	State
France	CHU de Bordeaux - service de médecine interne	Pessac

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Ministry for Health and Solidarity, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA)		At baseline (Day 0)