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Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA) (TFH and AIHA)

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ClinicalTrials.gov Identifier: NCT02828670
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : November 26, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief Summary:

T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known.

We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.


Condition or disease Intervention/treatment
Autoimmune Hemolytic Anemia Biological: blood sample Procedure: spleen sample

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
Actual Study Start Date : June 7, 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort Intervention/treatment
patient Biological: blood sample
Procedure: spleen sample
control Biological: blood sample
Procedure: spleen sample



Primary Outcome Measures :
  1. the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects. [ Time Frame: baseline ]
  2. the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids [ Time Frame: through study completion, an average of 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a diagnosis of warm AIHA Patients with non-auto-immune hemolytic anemia
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of warm AIHA defined by

    • Hemoglobin <11 g/dl
    • Low haptoglobin level
    • Positive direct antiglobulin test (IgG or IgG + complement)
    • Reticulocyte count >120 G/L
  • Patients

    • naive to treatment for hemolytic anemia or a in relapse
    • Older than 18 years
    • Able to understand written and spoken French
  • Persons who have provided written consent

Control population

  • Patients who have given consent
  • Patients over 18 years
  • Patients with cold agglutinin disease (progressive AIHA and different treatments of warm autoantibody AIHA) can be included as a sub-group of controls
  • Patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin, membrane-related,…) can be included as a sub-group of controls

Exclusion Criteria:

  • Patients without national health insurance
  • Pregnancy or breast-feeding women
  • Adults under guardianship
  • Patients with cancer or malignant hemopathy
  • Patients with an on-going infection
  • Patients treated with corticoids or immunosuppressants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02828670


Contacts
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Contact: Sylvain AUDIA 3.80.29.34.32 ext 33 sylvain.audia@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Sylvain AUDIA    3.80.29.34.32 ext 33    sylvain.audia@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02828670     History of Changes
Other Study ID Numbers: AUDIA APJ 2014
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases