Risk Factors and the Role of Albumin-to-globulin Ratio in Idiopathic Granulomatous Mastitis

Completed

• Conditions: Idiopathic Granulomatous Mastitis
• Interventions: Procedure: segmental mastectomy

• Registration Number: NCT05409586
• Lead Sponsor: Samsun Education and Research Hospital

Brief Summary

Albumin-to-globulin ratio (AGR) is an inflammation-based index that has been shown to have a role in many cancers and inflammatory diseases. Idiopathic granulomatous mastitis (IGM) is a rare inflammatory disease of the breast with a high recurrence rate. As a relatively new biomarker for inflammatory diseases, AGR's role in IGM recurrence has never been investigated in the literature. This study primarily investigates the possible risk factors for IGM recurrence and whether AGR can be used as a predictive factor.

Detailed Description

Patients diagnosed with IGM on pathology reports between January 2016 and March 2021 were enrolled in the study and their medical records were analyzed retrospectively. The patients were divided into two groups: recurrence and non-recurrence. Clinical, demographic characteristics, and laboratory parameters were compared. The best cut-off value for significant factors in predicting recurrence was determined by receiver operating characteristic (ROC) analysis. Univariate and multivariate logistic regression analysis was used to determine the risk factors that are effective in IGM recurrence.

Study Timeline

• Study Start: 2022-04-20
• Primary Completion: 2022-05-20
• Study Completion: 2022-05-25
• Study First Submitted: 2022-05-29
• Status Verified: 2022-06
• Study First Submitted QC: 2022-06-02
• Last Update Submitted: 2022-06-02
• Study First Posted: 2022-06-08
• Last Update Posted: 2022-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 109

Inclusion Criteria

• The patients with a pathologically confirmed diagnosis of granulomatous mastitis
• Patients over the age of 18
• Female patients

Exclusion Criteria

• Male patients
• Secondary granulomatous mastitis etiologies (tuberculous mastitis and Wegener's granulomatosis)
• Patients who do not have enough follow-up information
• Patients with missing data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no recurrence	segmental mastectomy	Patients who recovered after IGM treatment and had no signs of relapse
recurrence	segmental mastectomy	Patients whose symptoms reappear 3 months after IGM treatment

Primary Outcome Measures

Name	Time	Method
IGM recurrence	within an average of 3-4 years of follow-up after treatment	Recurrence was defined as the reappearance of breast complaints such as pain, mass, abscess, and fistula at the end of at least three months following remission with treatment. IGM developed in the other breast after the treatment was also accepted as a recurrent case.

Trial Locations

Locations (1)

Samsun Eğitim ve Araştırma Hastanesi; 🇹🇷 Samsun, Turkey