Immune Cells in Patients With Granulomatous Mastitis

Completed

• Conditions: Granulomatous Mastitis
• Interventions: Diagnostic Test: Flow cytometric immunophenotyping

• Registration Number: NCT04543149
• 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 immunophenotyping 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 lymphocyte subtypes in patients with granulomatous mastitis and to evaluate the differences in cell populations and its usability as a predictive marker in diagnosis.

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-09-03
• Study First Submitted QC: 2020-09-03
• Study First Posted: 2020-09-09
• Primary Completion: 2020-10-01
• Study Completion: 2020-10-10
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 35

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 immunophenotyping	Healthy volunteers
Case	Flow cytometric immunophenotyping	Patients with idiopathic granulomatous mastitis

Primary Outcome Measures

Name	Time	Method
To evaluate T cell subsets and monocyte ratio	3 months	CD3 (+) lymphocytes, CD4 (+) lymphocytes, CD 8 (+) lymphocytes, CD 3(-)/CD16 (+) NK cell ratio, CD14 (+) lymphocytes, and HLA-DR positivity on CD14 (+) cells

Trial Locations

Locations (1)

Istanbul Training and Research Hospital; 🇹🇷 Istanbul, Turkey