An observational study in Granulomatous Mastitis, sponsored by Istanbul Training and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-12.
Sponsored by Istanbul Training and Research Hospital · Observational
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.
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.
In case group patients with granulomatous mastitis will be included to the study. During diagnasis if the patient is diagnosed with tuberculosis, she will be excluded from the study.
Also healty volunteers who don't have breast lesions are control group.
Exclusion Criteria:
Patients with idiopathic granulomatous mastitis
Diagnostic Test: Flow cytometric immunophenotyping
Healthy volunteers
Diagnostic Test: Flow cytometric immunophenotyping
To evaluate T cell subsets and monocyte
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
Time frame: 3 months
Plan to share: Undecided
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Istanbul Training and Research Hospital