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临床试验/NCT05409586
NCT05409586已完成不适用

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

Samsun Education and Research Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2022年4月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
109
试验地点
1
主要终点
IGM recurrence

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

IGM recurrence

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Samsun Education and Research Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmet Burak Ciftci

Director

Samsun Education and Research Hospital

研究点 (1)

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