Granulomatous Mastitis Current Approach and Treatment

Granulomatous, Mastitis Clinical Trial

Official title:

Granulomatous Mastitis Current Approach and Treatment (Multicentric Study) Granulomatous Mastitis Working Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667132
• Other study ID #: GranulomatousMWG
• Status: Completed
• Phase: N/A
• First received: January 11, 2016
• Last updated: February 18, 2018
• Start date: December 2015
• Est. completion date: January 4, 2018

Study information

• Verified date: February 2018
• Source: Granulomatous Mastitis Working Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

INTRODUCTION Granulomatous mastitis (GM) is a rare inflammatory disease of the breast which generally affects young parous women. It was emphasized that lactation and using oral contraceptive are considered among the predisposing factors of the disease. GM is firstly identified in 1972, and it is considered as an important disease because it is a great mimicker of breast carcinoma.

The form of treatments involves corticosteroids, antibiotics and general surgical resections including mastectomy. Furthermore, a preferred form of treatment has not been defined yet. Also, there are not enough data showing the results of using antibiotics. Since GM is a rare disease, there is no common consensus for the diagnosis and treatment of GM. The uncertainties about the distinct diagnosis, determining the form and term of treatment, the order of treatment if necessary, as well as what medical specialties need to involve in the treatment process still remain. Therefore, all these uncertainties cause a difficulty to manage the treatment process by physicians. Furthermore, since there is no enough study on GM and only limited case reports was presented in the literature, the success of treatment process is associated with the experience of treatment center. Therefore, there is a clear need for multicentric study that compares different approaches of the treatment process with the enough number of cases.

DATA COLLECTION 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.). 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.

EXPECTED OUTCOMES

1. Potential etiologies will be investigated.

2. The results will shed light on the optimal management method for patients with GM.

3. The treatment duration and order will be revealed.

4. Treatment and management algorithm will be created.

5. The hypothesis on the success of ternary treatment approach will be tested.

6. Creation of a prognostic index for GM will be tried.

7. Since a multicentric study is planned, experiences and results from different centers will be investigated.

8. Since the study will be multicentric with enough number of cases, the true statistical results will be obtained.

9. Among which medical specialties should be involved in communication during the determination of diagnosis and treatment will be revealed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: January 4, 2018
• Est. primary completion date: January 3, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• All Granulomatous Mastitis

Exclusion Criteria:

• Breast Carcinoma

Related Conditions & MeSH terms

• Granulomatous Mastitis
• Granulomatous, Mastitis
• Mastitis

Locations

Country	Name	City	State
United States	Atilla Soran	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Granulomatous Mastitis Working Group

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kok 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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