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

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.

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Key information

Conditions

Idiopathic Granulomatous Mastitis Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Samsun Eğitim ve Araştırma Hastanesi

Samsun, 55090, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

segmental mastectomy

Procedure

The preferred method in the treatment of some patients diagnosed with IGM

Other names: Incision and Drainage

Primary outcomes

IGM recurrence

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Samsun Education and Research Hospital

Other

Registry information

Official study title

Evaluating the Risk Factors and the Role of Albumin-to-globulin Ratio in Predicting Recurrence Among Patients With Idiopathic Granulomatous Mastitis

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Jun 8, 2022
Registry last updated: Jun 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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