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

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Recruiting
CT.gov ID
NCT04005638
Collaborator
Ministry for Health and Solidarity, France (Other)
200
1
46.9
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: blood sample
  • Biological: urine sample

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Biological Bank for the Patients Followed in a Constitutive Reference Center for Autoimmune Cytopenia
Actual Study Start Date :
Feb 2, 2019
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Jan 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Autoimmune Cytopenia

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

Biological: urine sample
12 ml

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Bordeaux - service de médecine interne Pessac France

Sponsors and Collaborators

  • University Hospital, Bordeaux
  • Ministry for Health and Solidarity, France

Investigators

  • Principal Investigator: Jean-François VIALLARD, Prof, CHU Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT04005638
Other Study ID Numbers:
  • CHUBX 2018/13
First Posted:
Jul 2, 2019
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022