Trials / Completed
CompletedNCT04543149
Immune Cells in Patients With Granulomatous Mastitis
Evaluation of Immune Cells in Patients With Granulomatous Mastitis
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 35 (actual)
- Sponsor
- Istanbul Training and Research Hospital · Other Government
- Sex
- Female
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIAGNOSTIC_TEST | Flow cytometric immunophenotyping | To evaluate T cell subsets and monocyte |
Timeline
- Start date
- 2020-08-01
- Primary completion
- 2020-10-01
- Completion
- 2020-10-10
- First posted
- 2020-09-09
- Last updated
- 2021-01-12
Locations
1 site across 1 country: Turkey (Türkiye)
Source: ClinicalTrials.gov record NCT04543149. Inclusion in this directory is not an endorsement.