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

Idiopathic Granulomatous Mastitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05409586
• Other study ID #: SAMSUNERH.IGM
• Status: Completed
• Start date: April 20, 2022
• Est. completion date: May 25, 2022

Study information

• Verified date: June 2022
• Source: Samsun Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: May 25, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Granulomatous Mastitis
• Idiopathic Granulomatous Mastitis
• Mastitis

Intervention

Procedure:
• segmental mastectomy
The preferred method in the treatment of some patients diagnosed with IGM

Locations

Country	Name	City	State
Turkey	Samsun Egitim ve Arastirma Hastanesi	Samsun

Sponsors (1)

Lead Sponsor	Collaborator
Samsun Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Azizi A, Prasath V, Canner J, Gharib M, Sadat Fattahi A, Naser Forghani M, Sajjadi S, Farhadi E, Vasigh M, Kaviani A, Omranipour R, Habibi M. Idiopathic granulomatous mastitis: Management and predictors of recurrence in 474 patients. Breast J. 2020 Jul;26 — View Citation

Uysal E, Soran A, Sezgin E; Granulomatous Mastitis Study Group. Factors related to recurrence of idiopathic granulomatous mastitis: what do we learn from a multicentre study? ANZ J Surg. 2018 Jun;88(6):635-639. doi: 10.1111/ans.14115. Epub 2017 Jul 27. — View Citation

Velidedeoglu M, Kundaktepe BP, Aksan H, Uzun H. Preoperative Fibrinogen and Hematological Indexes in the Differential Diagnosis of Idiopathic Granulomatous Mastitis and Breast Cancer. Medicina (Kaunas). 2021 Jul 8;57(7). pii: 698. doi: 10.3390/medicina570 — View Citation

Xuan Q, Yang Y, Ji H, Tang S, Zhao J, Shao J, Wang J. Combination of the preoperative albumin to globulin ratio and neutrophil to lymphocyte ratio as a novel prognostic factor in patients with triple negative breast cancer. Cancer Manag Res. 2019 May 31;11:5125-5131. doi: 10.2147/CMAR.S195324. eCollection 2019. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGM recurrence	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.	within an average of 3-4 years of follow-up after treatment