Immune Cells in Patients With Granulomatous Mastitis

Study Overview
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Brief Summary
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Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that plays a role in many varying etiologies, including infectious and non-infectious causes. Etiological reasons were examined in various studies, but neither etiology nor definite criteria for diagnosis were found. Our aim in this study is to examine the role of immunophenotyping in differentiating the etiology of granulomatous mastitis and using it as a prognostic marker.

Detailed Description
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Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that plays a role in many varying aetiology, including infectious and non-infectious causes. This disease can clinically and radiographically mimic breast cancer, which can pose a diagnostic challenge as well as concern during evaluation. A nonspecific inflammatory response, 'granuloma' is defined as necrosis or infiltration of other inflammatory leukocytes, with or without mononuclear phagocyte collection. It is thought to be caused by infectious agents or foreign substances that activate the immune system, leading to granuloma formation. Some of the known inflammatory etiologies of granulomatous mastitis are autoimmune diseases such as tuberculosis (most commonly caused by Mycobacterium tuberculosis), sarcoidosis, fungal infection and granulomatosis with polyangiitis and giant cell arteritis. These diseases cannot be distinguished clinically, pathologically, and radiographically from idiopathic granulomatous mastitis.In this study, we aimed to investigate lymphocyte subtypes in patients with granulomatous mastitis and to evaluate the differences in cell populations and its usability as a predictive marker in diagnosis.

Official Title
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Evaluation of Immune Cells in Patients With Granulomatous Mastitis

Conditions
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Granulomatous Mastitis

Intervention / Treatment
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* Diagnostic Test: Flow cytometric immunophenotyping


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with granulomatous mastitis Exclusion Criteria: Cancer Patients Patients with known immunodeficiency Pregnancy Patient diagnosed with tuberculosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Case<br>Patients with idiopathic granulomatous mastitis | Diagnostic Test: Flow cytometric immunophenotyping<br>* To evaluate T cell subsets and monocyte<br>|
| Control<br>Healthy volunteers | Diagnostic Test: Flow cytometric immunophenotyping<br>* To evaluate T cell subsets and monocyte<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate T cell subsets and monocyte ratio | CD3 (+) lymphocytes, CD4 (+) lymphocytes, CD 8 (+) lymphocytes, CD 3(-)/CD16 (+) NK cell ratio, CD14 (+) lymphocytes, and HLA-DR positivity on CD14 (+) cells | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mastitis, immunophenotyping, Flow-cytometry