Clinical trial NCT04543149: Immune Cells in Patients With Granulomatous Mastitis
Official title: Evaluation of Immune Cells in Patients With Granulomatous Mastitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Granulomatous Mastitis
Keywords: Mastitis
immunophenotyping
Flow-cytometry
Lead sponsor: Istanbul Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-09-09
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In case group patients with granulomatous mastitis will be included to the study. During diagnasis if the patient is diagnosed with tuberculosis, she will be excluded from the study.

Also healty volunteers who don't have breast lesions are control group.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with granulomatous mastitis

Exclusion Criteria:

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

Primary outcomes:
measure: To evaluate T cell subsets and monocyte ratio
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Training and Research Hospital
Study officials:
affiliation: Istanbul Training and Research Hospital
name: Ufuk Oguz Idiz, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.