Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2026-01-03 @ 8:46 AM
Study NCT ID:
NCT02667132
Status:
COMPLETED
Last Update Posted:
2018-02-20
First Post:
2016-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Granulomatous Mastitis Current Approach and Treatment
Sponsor:
Granulomatous Mastitis Working Group
Organization:
Study Overview
Official Title:
Granulomatous Mastitis Current Approach and Treatment (Multicentric Study) Granulomatous Mastitis Working Group
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: