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

NCT ID: NCT05409586

Last Updated: 2022-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-20

Study Completion Date

2022-05-25

Brief Summary

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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

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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.

Conditions

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Idiopathic Granulomatous Mastitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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no recurrence

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

segmental mastectomy

Intervention Type PROCEDURE

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

recurrence

Patients whose symptoms reappear 3 months after IGM treatment

segmental mastectomy

Intervention Type PROCEDURE

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

Interventions

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segmental mastectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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Incision and Drainage

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Samsun Education and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Burak Ciftci

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Samsun Eğitim ve Araştırma Hastanesi

Samsun, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 31213922 (View on PubMed)

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.

Reference Type RESULT
PMID: 28749045 (View on PubMed)

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.

Reference Type RESULT
PMID: 32249491 (View on PubMed)

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.

Reference Type RESULT
PMID: 34356979 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36158516 (View on PubMed)

Other Identifiers

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SAMSUNERH.IGM

Identifier Type: -

Identifier Source: org_study_id

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