CClinicalTrials.gg
CompletedNCT05409586Updated Jun 8, 2022

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

An observational study in Idiopathic Granulomatous Mastitis, sponsored by Samsun Education and Research Hospital. Completed at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-08.

Sponsored by Samsun Education and Research Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
109
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Idiopathic Granulomatous Mastitis

Keywords

  • Idiopathic granulomatous mastitis
  • recurrence
  • albumin-to-globulin ratio
  • risk factors
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
109 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • Proceduresegmental mastectomy

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

    Also known as: Incision and Drainage

05

What researchers measure

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.

    Time frame: within an average of 3-4 years of follow-up after treatment

06

Study locations

1 site
  • Samsun Eğitim ve Araştırma Hastanesi
    Samsun, 55090, Turkey
07

References and documents

Publications

  • 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. PubMed 31213922 ↗
  • 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. PubMed 28749045 ↗
  • 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. PubMed 32249491 ↗
  • 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. PubMed 34356979 ↗
  • 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. PubMed 36158516 ↗

Individual participant data

Plan to share: Undecided — The datasets generated and analyzed in this study will be available from the corresponding author on reasonable request.

08

Registry details

Key details

Study ID
NCT05409586
Lead sponsor
Samsun Education and Research Hospital
Responsible party
Ahmet Burak Ciftci (Director, Samsun Education and Research Hospital) — Principal investigator
First posted
Jun 8, 2022
Start date
Apr 20, 2022
Primary completion
May 20, 2022
Completion
May 25, 2022
Last update
Jun 8, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion