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

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ClinicalTrials.gov Identifier: NCT04005638
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Ministry for Health and Solidarity, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date June 17, 2019
First Posted Date July 2, 2019
Last Update Posted Date July 2, 2019
Actual Study Start Date February 2, 2019
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2019)
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) ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and urine sample
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).
Condition
  • Immune Thrombocytopenia
  • Autoimmune Hemolytic Anemia
  • Autoimmune Neutropenia
Intervention
  • Biological: blood sample
    45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
  • Biological: urine sample
    12 ml
Study Groups/Cohorts Autoimmune Cytopenia
Interventions:
  • Biological: blood sample
  • Biological: urine sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 1, 2019)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2022
Estimated Primary Completion Date February 2022   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Jean-François VIALLARD, Prof 05.57.65.64.83 ext +33 jean-françois.viallard@chu-bordeaux.fr
Contact: Isabelle RAYMOND, Pharm isabelle.raymond@chu-bordeaux.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04005638
Other Study ID Numbers CHUBX 2018/13
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor University Hospital, Bordeaux
Collaborators Ministry for Health and Solidarity, France
Investigators
Principal Investigator: Jean-François VIALLARD, Prof CHU - Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date June 2019