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OpenTrials
Completed

NCT Number: NCT04540237

Serum Cytokine Values in Patients With Granulomatous Mastitis

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

Ufuk Oguz Idiz

Istanbul, 34371, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with granulomatous mastitis

Exclusion criteria

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

Treatment and study plan

Flow-cytometric analysis

Diagnostic Test

Flow-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

Primary outcomes

  1. Cytokine levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Istanbul Training and Research Hospital

Other Gov

Registry information

Official study title

Evaluation of Serum Cytokine Values in Patients With Granulomatous Mastitis

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2020
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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