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Granulomatous Mastitis Current Approach and Treatment

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ClinicalTrials.gov Identifier: NCT02667132
Recruitment Status : Completed
First Posted : January 28, 2016
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Granulomatous Mastitis Working Group

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.


Condition or disease
Granulomatous, Mastitis

Detailed 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.

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Study Type : Observational
Actual Enrollment : 400 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Granulomatous Mastitis Current Approach and Treatment (Multicentric Study) Granulomatous Mastitis Working Group
Study Start Date : December 2015
Actual Primary Completion Date : January 3, 2018
Actual Study Completion Date : January 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Group/Cohort
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



Primary Outcome Measures :
  1. Granulomatous Mastitis Working Group [ Time Frame: dec 2015 start data collection, February 2016 The primary outcome statement - April 2016 end up study ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
from 18 to 90 years womens with Granulomatous Mastitis
Criteria

Inclusion Criteria:

  • All Granulomatous Mastitis

Exclusion Criteria:

  • Breast Carcinoma

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02667132


Locations
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United States, Pennsylvania
Atilla Soran
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
Granulomatous Mastitis Working Group
Investigators
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Study Director: Atilla Soran, Professor Granulomatous Mastitis Working Group

Publications of Results:
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Responsible Party: Granulomatous Mastitis Working Group
ClinicalTrials.gov Identifier: NCT02667132     History of Changes
Other Study ID Numbers: GranulomatousMWG
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: February 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

Keywords provided by Granulomatous Mastitis Working Group:
Granulomatous, Mastitis
C17.800.090.968.400
C13.703.844.603.400

Additional relevant MeSH terms:
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Mastitis
Granulomatous Mastitis
Puerperal Disorders
Pregnancy Complications
Breast Diseases
Skin Diseases