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

NCT02828670 | Completed

• 1 other identifier: AUDIA APJ 2014
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (2)

• the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.

  baseline

• the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids

  through study completion, an average of 1 year

Study Arms (2)

patient

Biological: blood sample; Procedure: spleen sample

control

Biological: blood sample; Procedure: spleen sample

Interventions

blood sample BIOLOGICAL

control; patient

spleen sample PROCEDURE

control; patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 11, 2016
• Study Start: June 7, 2016
• Primary Completion: February 15, 2022
• Study Completion: February 15, 2022
• Last Updated: July 15, 2024

Record last verified: 2024-07

Locations

FR (1)