NCT04540237

Brief Summary

Granulomatous mastitis is a rare, chronic, benign inflammatory disease of the breast that plays a role in many varying etiologies, including infectious and non-infectious causes. Etiological reasons were examined in various studies, but neither etiology nor definite criteria for diagnosis were found. Our aim in this study is to examine the role of cytokines in differentiating the etiology of granulomatous mastitis and using it as a prognostic marker.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

September 3, 2020

Last Update Submit

January 11, 2021

Conditions

Granulomatous Mastitis

Keywords

MastitisCytokineFlow-cytometry

Outcome Measures

Primary Outcomes (1)

  • Cytokine levels

    IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 levels

    3 months

Study Arms (2)

Case

Patients with idiopathic granulomatous mastitis

Diagnostic Test: Flow-cytometric analysis

Control

Healthy volunteers

Diagnostic Test: Flow-cytometric analysis

Interventions

Flow-cytometric analysisDIAGNOSTIC_TEST

Flow-cytometric analysis of IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33

CaseControl

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsGranulomatous mastitis is observed in female patients.
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In case group patients with granulomatous mastitis will be included to the study. During diagnasis if the patient is diagnosed with tuberculosis, she will be excluded prom the study. Also healty volunteers without any breast diseases will be the control group

You may qualify if:

  • Patients with granulomatous mastitis

You may not qualify if:

  • Cancer Patients
  • Patients with known immunodeficiency
  • Pregnancy
  • Patient diagnosed with tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ufuk Oguz Idiz

Istanbul, 34371, Turkey (Türkiye)

Location

Related Publications (2)

  • Barreto DS, Sedgwick EL, Nagi CS, Benveniste AP. Granulomatous mastitis: etiology, imaging, pathology, treatment, and clinical findings. Breast Cancer Res Treat. 2018 Oct;171(3):527-534. doi: 10.1007/s10549-018-4870-3. Epub 2018 Jul 3.

    PMID: 29971624BACKGROUND

  • Skandarajah A, Marley L. Idiopathic granulomatous mastitis: a medical or surgical disease of the breast? ANZ J Surg. 2015 Dec;85(12):979-82. doi: 10.1111/ans.12929. Epub 2014 Nov 26.

    PMID: 25424519BACKGROUND

MeSH Terms

Conditions

Granulomatous MastitisMastitis

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ufuk Oguz Idiz, Assoc.Prof.

    Istanbul Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. MD

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 7, 2020

Study Start

September 1, 2020

Primary Completion

January 1, 2021

Study Completion

January 1, 2021

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

TU(1)