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

NCT05409586 | Completed

• 1 other identifier: SAMSUNERH.IGM
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Granulomatous Mastitis

Keywords

Idiopathic granulomatous mastitis; recurrence; albumin-to-globulin ratio; risk factors

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

no recurrence

Patients who recovered after IGM treatment and had no signs of relapse

Procedure: segmental mastectomy

recurrence

Patients whose symptoms reappear 3 months after IGM treatment

Procedure: segmental mastectomy

Interventions

segmental mastectomy PROCEDURE

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

Also known as: Incision and Drainage

no recurrence; recurrence

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients diagnosed with IGM on pathology reports between January 2016 and March 2021

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsun Education and Research Hospital: lead

Study Sites (1)

Samsun Eğitim ve Araştırma Hastanesi

Samsun, 55090, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 31213922 BACKGROUND

• 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.

  PMID: 28749045 RESULT

• 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(7):1358-1362. doi: 10.1111/tbj.13822. Epub 2020 Apr 5.

  PMID: 32249491 RESULT

• 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):698. doi: 10.3390/medicina57070698.

  PMID: 34356979 RESULT

• Ciftci AB, Buk OF, Yemez K, Polat S, Yazicioglu IM. Risk Factors and the Role of the Albumin-to-Globulin Ratio in Predicting Recurrence Among Patients with Idiopathic Granulomatous Mastitis. J Inflamm Res. 2022 Sep 18;15:5401-5412. doi: 10.2147/JIR.S377804. eCollection 2022.

  PMID: 36158516 DERIVED

MeSH Terms

Conditions

Recurrence

Interventions

Mastectomy, Segmental; Drainage

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative; Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 29, 2022
• First Posted: June 8, 2022
• Study Start: April 20, 2022
• Primary Completion: May 20, 2022
• Study Completion: May 25, 2022
• Last Updated: June 8, 2022

Record last verified: 2022-06

Locations

TU (1)