Serum Cytokine Values in Patients With Granulomatous Mastitis

Completed

• Conditions: Granulomatous Mastitis
• Interventions: Diagnostic Test: Flow-cytometric analysis

• Registration Number: NCT04540237
• Lead Sponsor: Istanbul Training and Research Hospital

Brief 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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-07
• Status Verified: 2021-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• Patients with granulomatous mastitis

Exclusion Criteria

• Cancer Patients
• Patients with known immunodeficiency
• Pregnancy
• Patient diagnosed with tuberculosis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Flow-cytometric analysis	Healthy volunteers
Case	Flow-cytometric analysis	Patients with idiopathic granulomatous mastitis

Primary Outcome Measures

Name	Time	Method
Cytokine levels	3 months	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

Trial Locations

Locations (1)

Ufuk Oguz Idiz; 🇹🇷 Istanbul, Turkey