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

NCT ID: NCT02828670

Last Updated: 2024-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-07

Study Completion Date

2022-02-15

Brief Summary

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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.

Detailed Description

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Conditions

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Autoimmune Hemolytic Anemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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patient

blood sample

Intervention Type BIOLOGICAL

spleen sample

Intervention Type PROCEDURE

control

blood sample

Intervention Type BIOLOGICAL

spleen sample

Intervention Type PROCEDURE

Interventions

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blood sample

Intervention Type BIOLOGICAL

spleen sample

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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AUDIA APJ 2014

Identifier Type: -

Identifier Source: org_study_id

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