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CompletedNCT04540237

Serum Cytokine Values in Patients With Granulomatous Mastitis

Evaluation of Serum Cytokine Values in Patients With Granulomatous Mastitis

Status
Completed
Phase
Study type
Observational
Enrollment
50 (actual)
Sponsor
Istanbul Training and Research Hospital · Other Government
Sex
Female
Age
18 Years – 80 Years
Healthy volunteers

Summary

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 cytokines in differentiating the etiology of granulomatous mastitis and using it as a prognostic marker.

Detailed description

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 IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 levels in patients with granulomatous mastitis and to evaluate the differences in cytokine levels and its usability as a predictive marker in diagnosis.

Conditions

Interventions

TypeNameDescription
DIAGNOSTIC_TESTFlow-cytometric analysisFlow-cytometric analysis of IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33

Timeline

Start date
2020-09-01
Primary completion
2021-01-01
Completion
2021-01-01
First posted
2020-09-07
Last updated
2021-01-12

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT04540237. Inclusion in this directory is not an endorsement.