Clinical trial NCT04005638: Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia
Official title: Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immune Thrombocytopenia
Autoimmune Hemolytic Anemia
Autoimmune Neutropenia
Keywords: Biological collection
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Ministry for Health and Solidarity, France
First posted: 2019-07-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with autoimmune cytopenia according to the definitions reported in the latest update of the French National Care Protocol (PNDS 2017).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with autoimmune cytopenia at diagnosis, or followed but not treated with a biological library (serum, plasma, DNA)
timeFrame: At baseline (Day 0)
Secondary outcomes:
Other outcomes:
Locations:
city: Pessac
country: France
facility: CHU de Bordeaux - service de médecine interne
Study officials:
affiliation: University Hospital, Bordeaux
name: Jean-François VIALLARD, Prof
role: PRINCIPAL_INVESTIGATOR
References: