Serum Cytokine Values in Patients With Granulomatous Mastitis

NCT ID: NCT04540237

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-01
• Study Completion Date: 2021-01-01

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.

Conditions

Granulomatous Mastitis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Case

Patients with idiopathic granulomatous mastitis

Flow-cytometric analysis

Intervention Type: 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

Control

Healthy volunteers

Flow-cytometric analysis

Intervention Type: 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

Interventions

Flow-cytometric analysis

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with granulomatous mastitis

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istanbul Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ufuk Oguz Idiz

Assoc. Prof. MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ufuk Oguz Idiz, Assoc.Prof.

Role: PRINCIPAL_INVESTIGATOR

Istanbul Training and Research Hospital

Locations

Ufuk Oguz Idiz

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Barreto DS, Sedgwick EL, Nagi CS, Benveniste AP. Granulomatous mastitis: etiology, imaging, pathology, treatment, and clinical findings. Breast Cancer Res Treat. 2018 Oct;171(3):527-534. doi: 10.1007/s10549-018-4870-3. Epub 2018 Jul 3.

Reference Type: BACKGROUND

PMID: 29971624 (View on PubMed)

Skandarajah A, Marley L. Idiopathic granulomatous mastitis: a medical or surgical disease of the breast? ANZ J Surg. 2015 Dec;85(12):979-82. doi: 10.1111/ans.12929. Epub 2014 Nov 26.

Reference Type: BACKGROUND

PMID: 25424519 (View on PubMed)

Other Identifiers

Mastitis cytokine

Identifier Type: -

Identifier Source: org_study_id