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

June 2, 2022 updated by: Ahmet Burak Ciftci, Samsun Education and Research Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Samsun, Turkey, 55090
        • Samsun Eğitim ve Araştırma Hastanesi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
no recurrence
Patients who recovered after IGM treatment and had no signs of relapse
Procedure: segmental mastectomy
The preferred method in the treatment of some patients diagnosed with IGM
Other Names:
  • Incision and Drainage
recurrence
Patients whose symptoms reappear 3 months after IGM treatment
Procedure: segmental mastectomy
The preferred method in the treatment of some patients diagnosed with IGM
Other Names:
  • Incision and Drainage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within an average of 3-4 years of follow-up after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsun Education and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 20, 2022

Primary Completion (ACTUAL)

May 20, 2022

Study Completion (ACTUAL)

May 25, 2022

Study Registration Dates

First Submitted

May 29, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (ACTUAL)

June 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

June 8, 2022

Last Update Submitted That Met QC Criteria

June 2, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SAMSUNERH.IGM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The datasets generated and analyzed in this study will be available from the corresponding author on reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Idiopathic Granulomatous Mastitis

Clinical Trials on segmental mastectomy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe