Immune Cells in Patients With Granulomatous Mastitis

NCT04543149 | Completed DMC

• 1 other identifier: Granulomatous mastitis cell
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Granulomatous Mastitis

Keywords

Mastitis; immunophenotyping; Flow-cytometry

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Case

Patients with idiopathic granulomatous mastitis

Diagnostic Test: Flow cytometric immunophenotyping

Control

Healthy volunteers

Diagnostic Test: Flow cytometric immunophenotyping

Interventions

Flow cytometric immunophenotyping DIAGNOSTIC_TEST

To evaluate T cell subsets and monocyte

Case; Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Granulomatous mastitis is observed in female patients.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients with granulomatous mastitis

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Training and Research Hospital: lead

Study Sites (1)

Istanbul Training and Research Hospital

Istanbul, 34371, Turkey (Türkiye)

Location

Related 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.

  PMID: 29971624 BACKGROUND

• 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.

  PMID: 25424519 BACKGROUND

MeSH Terms

Conditions

Granulomatous Mastitis; Mastitis

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ufuk Oguz Idiz, Assoc.Prof.

  Istanbul Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. MD

Study Record Dates

• First Submitted: September 3, 2020
• First Posted: September 9, 2020
• Study Start: August 1, 2020
• Primary Completion: October 1, 2020
• Study Completion: October 10, 2020
• Last Updated: January 12, 2021

Record last verified: 2021-01

Locations

TU (1)