Immunopathology of Autoimmune Hemolytic Anemia

NCT ID: NCT02158195

Last Updated: 2022-09-21

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

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-07-03

Study Completion Date

2018-12-27

Brief Summary

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Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.

The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.

The role of treatments, such as steroids, will also be determined in patients with warm AIHA.

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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Patients

blood samples

Intervention Type BIOLOGICAL

controls

blood samples

Intervention Type BIOLOGICAL

Interventions

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blood samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)
* Secondary AHAI (infections, hematological diseases, systemic diseases)
* Naive of treatment for hemolytic anemia or in relapse
* Older than 16
* Able to understand written and spoken French
* who have provided written informed consent
* Persons without auto-immune disease, cancer or active infection.
* Older than 16
* Able to understand written and spoken French
* who have provided written informed consent

Exclusion Criteria

* Cold agglutinin disease
* Pregnancy
* Persons without national health insurance


* Subjects treated with corticosteroids or immunosuppressants
* Pregnancy
* Persons without national health insurance
Minimum Eligible Age

16 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 de Besançon

Besançon, , France

Site Status

CH de Chalon-sur-Saône

Chalon-sur-Saône, , France

Site Status

CHU de DIJON

Dijon, , France

Site Status

CH de Mâcon

Mâcon, , France

Site Status

CH de METZ

Metz, , France

Site Status

Countries

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France

References

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Ciudad M, Ouandji S, Lamarthee B, Cladiere C, Ghesquiere T, Nivet M, Thebault M, Boidot R, Soudry-Faure A, Chevrier S, Richard C, Maillet T, Maurier F, Greigert H, Genet C, Ramon A, Trad M, Predan V, Saas P, Samson M, Bonnotte B, Audia S. Regulatory T-cell dysfunctions are associated with increase in tumor necrosis factor alpha in autoimmune hemolytic anemia and participate in Th17 polarization. Haematologica. 2024 Feb 1;109(2):444-457. doi: 10.3324/haematol.2023.282859.

Reference Type DERIVED
PMID: 37534543 (View on PubMed)

Audia S, Bach B, Samson M, Lakomy D, Bour JB, Burlet B, Guy J, Duvillard L, Branger M, Leguy-Seguin V, Berthier S, Michel M, Bonnotte B. Venous thromboembolic events during warm autoimmune hemolytic anemia. PLoS One. 2018 Nov 8;13(11):e0207218. doi: 10.1371/journal.pone.0207218. eCollection 2018.

Reference Type DERIVED
PMID: 30408135 (View on PubMed)

Other Identifiers

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AUDIA APJ 2012

Identifier Type: -

Identifier Source: org_study_id

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