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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

Tracking Information
First Submitted Date June 23, 2016
First Posted Date July 11, 2016
Last Update Posted Date November 26, 2018
Actual Study Start Date June 7, 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 12, 2018)
  • the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects. [ Time Frame: 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 ]
Original Primary Outcome Measures
 (submitted: July 7, 2016)
  • Compare the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis, with the proportion of circulating T follicular helper lymphocytes (TFH) in control subjects. [ Time Frame: day one ]
  • number of T follicular helper lymphocytes in the blood when patients are treated with corticoids [ Time Frame: through study completion, an average of 1 year ]
Change History Complete list of historical versions of study NCT02828670 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
Official Title Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with a diagnosis of warm AIHA Patients with non-auto-immune hemolytic anemia
Condition Autoimmune Hemolytic Anemia
Intervention
  • Biological: blood sample
  • Procedure: spleen sample
Study Groups/Cohorts
  • patient
    Interventions:
    • Biological: blood sample
    • Procedure: spleen sample
  • control
    Interventions:
    • Biological: blood sample
    • Procedure: spleen sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 7, 2016)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sylvain AUDIA 3.80.29.34.32 ext 33 sylvain.audia@chu-dijon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02828670
Other Study ID Numbers AUDIA APJ 2014
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date March 2018