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

NCT ID: NCT04005638

Last Updated: 2025-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-02-02

Study Completion Date

2027-01-31

Brief Summary

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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

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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.

Conditions

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Immune Thrombocytopenia Autoimmune Hemolytic Anemia Autoimmune Neutropenia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Autoimmune Cytopenia

blood sample

Intervention Type BIOLOGICAL

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

urine sample

Intervention Type BIOLOGICAL

12 ml

Interventions

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blood sample

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

Intervention Type BIOLOGICAL

urine sample

12 ml

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry for Health and Solidarity, France

OTHER_GOV

Sponsor Role collaborator

University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-François VIALLARD, Prof

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux - service de médecine interne

Pessac, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François VIALLARD, Prof

Role: CONTACT

05.57.65.64.83 ext. +33

Isabelle RAYMOND, Pharm

Role: CONTACT

Facility Contacts

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Jean-François VIALLARD, Prof

Role: primary

05.57.65.64.83 ext. +33

Isabelle RAYMOND, Pharm

Role: backup

Other Identifiers

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CHUBX 2018/13

Identifier Type: -

Identifier Source: org_study_id

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