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

July 12, 2024 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Chu Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with a diagnosis of warm AIHA Patients with non-auto-immune hemolytic anemia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.
Time Frame: baseline
baseline
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
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 7, 2016

Primary Completion (Actual)

February 15, 2022

Study Completion (Actual)

February 15, 2022

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimated)

July 11, 2016

Study Record Updates

Last Update Posted (Actual)

July 15, 2024

Last Update Submitted That Met QC Criteria

July 12, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUDIA APJ 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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