Granulomatous, MastitisNCT02667132
Granulomatous Mastitis Current Approach and Treatment
An observational study of Granulomatous, Mastitis, run by Granulomatous Mastitis Working Group at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Granulomatous, Mastitis
- Type of treatment
- Pill or oral medicine
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 4 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: from 18 to 90 years womens with Granulomatous Mastitis
Who may be able to join
- All Granulomatous Mastitis
Who cannot join
- Breast Carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Granulomatous Mastitis Current Approach and Treatment (Multicentric Study) Granulomatous Mastitis Working Group
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.
Read the 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
- Potential etiologies will be investigated.
- The results will shed light on the optimal management method for patients with GM.
- The treatment duration and order will be revealed.
- Treatment and management algorithm will be created.
- The hypothesis on the success of ternary treatment approach will be tested.
- Creation of a prognostic index for GM will be tried.
- Since a multicentric study is planned, experiences and results from different centers will be investigated.
- Since the study will be multicentric with enough number of cases, the true statistical results will be obtained.
- Among which medical specialties should be involved in communication during the determination of diagnosis and treatment will be revealed.
- Conditions
- Granulomatous, Mastitis
- Keywords
- Granulomatous, Mastitis, C17.800.090.968.400, C13.703.844.603.400
- Medical subject headings
- Granulomatous Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: dec 2015 start data collection, February 2016 The primary outcome statement - April 2016 end up study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startDec 2015
- Primary completion3 Jan 2018
- Study completion4 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Granulomatous, MastitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Granulomatous Mastitis Working Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Atilla Soran, Professor, Study director, Granulomatous Mastitis Working Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667132
- Sponsor's protocol ID
- GranulomatousMWG
- Status last verified
- Feb 2018
- First submitted
- 11 Jan 2016
- Last updated
- 20 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 16502488Kok 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.
PubMed 20569938
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulomatous Mastitis Current Approach and Treatment (Multicentric Study) Granulomatous Mastitis Working Group
- ClinicalTrials.gov ID
- NCT02667132
- Acronym / sponsor ID
- GranulomatousMWG
- Conditions
- Granulomatous, Mastitis
- Keywords
- Granulomatous, Mastitis, C17.800.090.968.400, C13.703.844.603.400
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Granulomatous Mastitis Working GroupUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- 3 Jan 2018 (actual)
- Study completion
- 4 Jan 2018 (actual)
- First posted
- 28 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Potential etiologies will be investigated.
- The results will shed light on the optimal management method for patients with GM.
- The treatment duration and order will be revealed.
- Treatment and management algorithm will be created.
- The hypothesis on the success of ternary treatment approach will be tested.
- Creation of a prognostic index for GM will be tried.
- Since a multicentric study is planned, experiences and results from different centers will be investigated.
- Since the study will be multicentric with enough number of cases, the true statistical results will be obtained.
- Among which medical specialties should be involved in communication during the determination of diagnosis and treatment will be revealed.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- from 18 to 90 years womens with Granulomatous Mastitis
Key inclusion criteria (1 listed)
- All Granulomatous Mastitis
Key exclusion criteria (1 listed)
- Breast Carcinoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2018.
- Results publication: PubMed 16502488Lee 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.
- Results publication: PubMed 20569938Kok 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atilla Soran, Professor study director
Granulomatous Mastitis Working Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Granulomatous, Mastitis, run by Granulomatous Mastitis Working Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Granulomatous Mastitis Working Group (time frame: dec 2015 start data collection, February 2016 The primary outcome statement - April 2016 end up study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02667132, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2018.