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CompletedNCT02828670TFH and AIHAUpdated Jul 15, 2024

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

An observational study in Autoimmune Hemolytic Anemia, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-15.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
25
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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In context

Anemia

1,733 studies on the registry are indexed under Anemia; 246 are open to participants now.

This study's enrollment of 25 is below the median of 200 across 326 observational studies indexed under Anemia.

Browse Anemia studies →

Lead sponsor

Centre Hospitalier Universitaire Dijon is the lead sponsor of 495 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
25 participants (actual)
Patient registry
No

Groups and cohorts

  • patient

    Biological: blood sample · Procedure: spleen sample

  • control

    Biological: blood sample · Procedure: spleen sample

Interventions

  • Biologicalblood sample
  • Procedurespleen sample
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What researchers measure

Primary outcomes

  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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Study locations

1 site
  • CHU Dijon Bourgogne
    Dijon, 21079, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02828670
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Jul 11, 2016
Start date
Jun 7, 2016
Primary completion
Feb 15, 2022
Completion
Feb 15, 2022
Last update
Jul 15, 2024
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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