Immune Cells in Patients With Granulomatous Mastitis

Granulomatous Mastitis Clinical Trial

Official title:

Evaluation of Immune Cells in Patients With Granulomatous Mastitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04543149
• Other study ID #: Granulomatous mastitis cell
• Status: Completed
• Start date: August 1, 2020
• Est. completion date: October 10, 2020

Study information

• Verified date: January 2021
• Source: Istanbul Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: October 10, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with granulomatous mastitis

Exclusion Criteria:

• Cancer Patients

• Patients with known immunodeficiency

• Pregnancy

• Patient diagnosed with tuberculosis

Related Conditions & MeSH terms

• Granulomatous Mastitis
• Mastitis

Intervention

Diagnostic Test:
• Flow cytometric immunophenotyping
To evaluate T cell subsets and monocyte

Locations

Country	Name	City	State
Turkey	Istanbul Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate T cell subsets and monocyte ratio	CD3 (+) lymphocytes, CD4 (+) lymphocytes, CD 8 (+) lymphocytes, CD 3(-)/CD16 (+) NK cell ratio, CD14 (+) lymphocytes, and HLA-DR positivity on CD14 (+) cells	3 months