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Immune Cells in Patients With Granulomatous Mastitis

Evaluation of Immune Cells in Patients With Granulomatous Mastitis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04543149
Enrollment
35
Registered
2020-09-09
Start date
2020-08-01
Completion date
2020-10-10
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granulomatous Mastitis

Keywords

Mastitis, immunophenotyping, Flow-cytometry

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.

Interventions

To evaluate T cell subsets and monocyte

Sponsors

Istanbul Training and Research Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients with granulomatous mastitis

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
To evaluate T cell subsets and monocyte ratio3 monthsCD3 (+) lymphocytes, CD4 (+) lymphocytes, CD 8 (+) lymphocytes, CD 3(-)/CD16 (+) NK cell ratio, CD14 (+) lymphocytes, and HLA-DR positivity on CD14 (+) cells

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026