Granulomatous Mastitis Current Approach and Treatment
1 other identifier
observational
400
1 country
1
Brief Summary
The aim of this study was to retrospectively review the granulomatous mastitis and evaluated current approach and treatment. HYPOTHESIS Although there is no common protocol for the treatment and management process of GM, the ternary treatment (medical treatment following by surgical procedure, Steroid+Antibiotic and surgical procedure, respectively) is considered as the most successful treatment approach.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 11, 2016
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 4, 2018
CompletedFebruary 20, 2018
February 1, 2018
2.1 years
January 11, 2016
February 18, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Granulomatous Mastitis Working Group
The data includes the determined parameters by the study group of GM and the data will be recorded in an excel file that includes specific columns of the following entries: patients' age, diagnosis, secondary disease, diagnosis methods, treatments, recurrence, the risk factors that may cause the disease. A shared excel file at the following website http://sanko.edu.tr/GranulamatozMastit has been created to record the data simultaneously. Each researcher can add the data at the file by using username and password. After data collection, statistical analysis will include Mann-Whitney U test, student's t test and chi-square test and statistical significance will set at P\< 0.05.The sample size and power analysis were conducted and the results indicated that at least 100 samples in each group are required to achieve the statistical significance at P\< 0.05 with 90% power. The estimated total cases are expected over 400 cases.
dec 2015 start data collection, February 2016 The primary outcome statement - April 2016 end up study
Study Arms (3)
medical treatment
In this study, patient's data will be retrospectively obtained by recording the data in patients' files and electronic records. The data includes the determined parameters by the study group of GM and the data will be recorded in an excel file that includes specific columns of the following entries: patients' age, diagnosis, secondary disease, diagnosis methods, treatments, recurrence, the risk factors that may cause the disease (smoking, using oral contraceptive, breast infection etc.). antibiotic, immunosuppressive drugs, methotrexate
surgical treatment
lumpectomy, mastectomy, abscess drainage
surgical+medical treatment
first medical, after surgical treatment or first surgical, after medical treatment
Eligibility Criteria
from 18 to 90 years womens with Granulomatous Mastitis
You may qualify if:
- All Granulomatous Mastitis
You may not qualify if:
- Breast Carcinoma
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Atilla Soran
Pittsburgh, Pennsylvania, 15261, United States
Related Publications (2)
Lee JH, Oh KK, Kim EK, Kwack KS, Jung WH, Lee HK. Radiologic and clinical features of idiopathic granulomatous lobular mastitis mimicking advanced breast cancer. Yonsei Med J. 2006 Feb 28;47(1):78-84. doi: 10.3349/ymj.2006.47.1.78.
PMID: 16502488RESULTKok KY, Telisinghe PU. Granulomatous mastitis: presentation, treatment and outcome in 43 patients. Surgeon. 2010 Aug;8(4):197-201. doi: 10.1016/j.surge.2010.02.002. Epub 2010 Mar 6.
PMID: 20569938RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Atilla Soran, Professor
Granulomatous Mastitis Working Group
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 11, 2016
First Posted
January 28, 2016
Study Start
December 1, 2015
Primary Completion
January 3, 2018
Study Completion
January 4, 2018
Last Updated
February 20, 2018
Record last verified: 2018-02
Data Sharing
- IPD Sharing
- Will share
DATA COLLECTION A shared excel file at the following website http://sanko.edu.tr/GranulamatozMastit has been created to record the data simultaneously. Each researcher can add the data at the file by using username and password. After data collection, the data will be presented mean+StDv. Statistical analysis will include Mann-Whitney U test, student's t test and chi-square test and statistical significance will set at P\< 0.05. The treatment group in this study will be divided as medical, surgical and medical+surgical and the comparison among these groups will be conducted to reach the aims determined in expected outcomes section. The sample size and power analysis were conducted and the results indicated that at least 100 samples in each group are required to achieve the statistical significance at P\< 0.05 with 90% power. The estimated total cases are expected over 400 cases.