Idiopathic Granulomatous MastitisIGM-COMBONCT05361629
Idiopathic Granulomatous Mastitis Combination Therapy
A study testing Intralesional steroid administration and Intraoperative cavity steroid administration in people with Idiopathic Granulomatous Mastitis, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
After breast cancer, diopathic Granulomatous Mastitis (IGM) is among the breast diseases that bother patients and clinicians the most. Countries with a coast to the Mediterranean, especially our country, are the most common geography of this disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Idiopathic Granulomatous Mastitis
- What is being tested?
- Intralesional steroid administration and Intraoperative cavity steroid administration
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 Apr 2022to Sep 2023
- Phase
- Interventional
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with IGM histopathologically
- Patients in groups A, B and C according to clinical classification
- Ultrasonographically; Patients with leaf-like hypoechoic type, localized abscess type, and localized hypoechoic mass type mastitis
Who cannot join
- Patients diagnosed with tumor after biopsy
- Those with TB PCR (+)
- Presence of clinically widespread abscess and cellulite (group D patients)
- Ultrasonographically; diffuse diffuse type
- Pregnancy
- Breastfeeding period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Baskent University Adana Teaching Hospital
Adana, Yuregir, 01120
Ozgur Aytac, MD, 5326529343, oaytac@gmail.com
About this study
Official title: The Effect of the Combination of Excision and Intraoperative Steroid Administration in Idiopathic Granulomatous Mastitis
After breast cancer, diopathic Granulomatous Mastitis (IGM) is among the breast diseases that bother patients and clinicians the most. Countries with a coast to the Mediterranean, especially our country, are the most common geography of this disease. For this reason, a significant part of the important scientific publications about IGM in the last 3-4 decades are from the countries of this geography and mainly from our country. The paradigm of whether IGM should be treated medically or surgically is still a matter of debate. Today, effective treatment results can be achieved with medical treatments, and local drug applications are finding an increasing application area in order to reduce the systemic drug level due to the side effects often seen in this process. As in the centers dealing with breast diseases intensively in our country, patients are treated in our center both by systemic and local means.
Within the body of the Turkish Breast Diseases Federation, after the plans made with the employees of the leading breast centers of the International Breast Health Working Group International planned to start a recording study to observe the activity between, local treatment in the lesion without surgical treatment with systemic treatment in IGM treatment and local treatment together with surgical treatment.
Read the detailed description
AIM:
Primary: The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on the shortening of the recovery period in Idiopathic Granulomatous Mastitis.
Secondary: Comparison of the side effects and the relationship between the treatment method and the serum cortisol level in patients treated with intralesional steroid + low dose oral steroid and topical steroid
THE WORK PLAN:
A prospective registry study was designed to compare the effectiveness of the combination of intralesional steroid administration used in the treatment of IGM + low-dose oral steroid therapy used together with the combination of surgical excision and intraoperative intra-cavity steroid administration.
For this purpose, it was planned to observe treatment success rates, time to treatment, recurrence rates at the earliest 1 year follow-up, and side effects related to surgical oral steroid use in eligible IGM patients treated in two different treatment groups.
METHOD:
After clinical and radiological evaluation, histopathological examination will be performed from core biopsy samples taken under ultrasound guidance and tuberculosis (TB) PCR and microbiological culture evaluation will be performed in all patients to rule out specific granulomatous inflammation. Patients with granulmatous inflammation characterized by histopathologically noncaseating granulomas, TB PCR negative and without culture growth, who meet the inclusion criteria, will be recruited into one of the two main treatment arms, at the discretion of the treating centre. There will be no randomization in determining the method of treatment. The type of treatment will be chosen according to the facilities of the performing center, especially the availability of intermittent access to the hospital for non-surgical treatment, and the priority to be determined between the patient and the physician. Since the efficiency superiority between the two methods is not known, any one will not be prioritized and the choice of treatment method will be determined by the patient and the physician. Among these patients, in those with localized abscess type IGM, the abscess foci that are present at the stage of sampling for TB PCR, microbiology culture and histopathology evaluation will be completely aspirated before the treatment is started, and will be waited until the sample results are obtained.
Treatment arms:
Group 1 (NON-SURGERY GROUP): Intralesional steroid + Low dose oral steroid (<30 mg/day prednol) Group 2 (SURGERY GROUP): Excision + Intraoperative steroid injection
Group 1: Patients whose serum cortisol level was observed before starting the treatment, who were injected with 40 mg of prednol at 4 weeks intervals for 3 months for each lesion. The total monthly dose will not exceed 120 mg, and the total 3-month dose will not exceed 200 mg. In this group of patients, the serum cortisol level should have reappeared on the 2nd or 3rd day following each intralesional administration. In this group of patients, low-dose oral prednol (<30 mg/day) and/or topical prednol cream can be applied twice a day during the treatment.
In patients included in Group 2, serum cortisol levels should have been observed before starting treatment. Then the patients should be operated and the mass(s) should be excised. Intraoperatively, not less than 40 mg of prednol should be injected into each mass cavity (it may vary according to the cavity diameter), and the amount applied to all cavities should not exceed 200 mg in total. The amount of prednol administered for each cavity should be recorded. In this group of patients, prednol may have been administered to the cavity walls (Group 2a) or inside the cavity (Group 2b). Serum cortisol levels should be seen in patients 7 to 10 days after the procedure.
Group 2a: 4 Quadrants 40 mg predmol per cavity wall (for < 2 cm lesion and an additional 20 mg for each additional 1 cm) Group 2b: 40 mg predmol into the cavity (for < 2 cm lesion and an additional 20 mg for each additional 1 cm)
Monitoring parameters:
- Recovery rates
- Time to recovery
- Recurrence rates after one-year follow-up
- Complications / side effects due to surgery or oral steroid use
- Relationship between steroid administration method and serum cortisol level Recovery (remission) was defined as the complete disappearance of pre-treatment clinical and ultrasonographic mastitis findings for patients in Group 1, and completion of wound healing for patients in Group 2.
Relapse was defined as the clinical or ultrasonographic re-detection of the disease in the same breast in both groups, following remission, in a similar or different type to the pre-treatment. Any need for repetitive surgery in the surgical arm will also be considered a recurrence.
In case of relapse in patients in both groups, the continuation of treatment will be left to the choice of centers.
- Conditions
- Idiopathic Granulomatous Mastitis
- Being tested
- Intralesional steroid administration, Intraoperative cavity steroid administration
- Keywords
- Idiopathic granulomatous mastitis, Steroid injection, Topical steroid, Steroid injection to surgical cavity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intralesional steroid administrationProcedure or surgery
Treatment by administering steroids into the lesion
Intraoperative cavity steroid administrationProcedure or surgery
Treatment by administering steroids into the surgical cavity
| Study group | Role | What they receive |
|---|---|---|
| NON-SURGERY GROUP | Active comparator | Group 1: Patients whose serum cortisol level was observed before starting the treatment, who were injected with 40 mg of prednol at 4 weeks intervals for 3 months for each lesion. The total monthly dose will not exceed 120 mg, and the total 3-month dose will not exceed 200 mg. In this group of patients, the serum cortisol level should have reappeared on the 2nd or 3rd day following each intralesional administration. In this group of patients, low-dose oral prednol (<30 mg/day) and/or topical prednol cream can be applied twice a day during the treatment. Receives: Procedure: Intralesional steroid administration |
| SURGERY GROUP | Active comparator | In patients included in Group 2, serum cortisol levels should have been observed before starting treatment. Then the patients should be operated and the mass(s) should be excised. Intraoperatively, not less than 40 mg of prednol should be injected into each mass cavity (it may vary according to the cavity diameter), and the amount applied to all cavities should not exceed 200 mg in total. The amount of prednol administered for each cavity should be recorded. In this group of patients, prednol may have been administered to the cavity walls (Group 2a) or inside the cavity (Group 2b). Serum cortisol levels should be seen in patients 7 to 10 days after the procedure.
Group 2a: 4 Quadrants 40 mg predmol per cavity wall (for < 2cm lesion and an additional 20 mg for each additional 1 cm) Group 2b: 40 mg predmol into the cavity (for < 2 cm lesion and an additional 20 mg for each additional 1 cm) Receives: Procedure: Intraoperative cavity steroid administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of excision and intraoperative steroid administration to the cavity in Idiopathic Granulomatous Mastitis.
The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on outcome in Idiopathic Granulomatous Mastitis.
Measured: one year
Secondary outcomes (2)
Rate of side effects in patients who received intralesional steroid
Comparison of side effect rates in patients treated with intralesional steroids +/- low-dose oral steroids and/or topical steroids.
Measured: one year
Correlation of treatment modality and serum cortisol levels.
Correlation of treatment modality and serum cortisol levels in patients treated with intralesional steroids +/- low-dose oral steroids and/or topical steroids.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start16 Apr 2022
- Primary completionApr 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huseyin Ozgur Aytac, Baskent University
- Investigators
- Ozgur Aytac, MD, Study director, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361629
- Sponsor's protocol ID
- MF 22-02
- Acronym
- IGM-COMBO
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hu T, Li S, Huang H, Huang H, Tan L, Chen Y, Deng H, Wu J, Zhu L, Zhang J, Su F, Chen K. Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. BMJ Open. 2020 Oct 10;10(10):e036643. doi: 10.1136/bmjopen-2019-036643.
PubMed 33039992Ma X, Min X, Yao C. Different Treatments for Granulomatous Lobular Mastitis: A Systematic Review and Meta-Analysis. Breast Care (Basel). 2020 Feb;15(1):60-66. doi: 10.1159/000501498. Epub 2019 Jul 10.
PubMed 32231499Zhou F, Liu L, Liu L, Yu L, Wang F, Xiang Y, Zheng C, Huang S, Cai H, Yu Z. Comparison of Conservative versus Surgical Treatment Protocols in Treating Idiopathic Granulomatous Mastitis: A Meta-Analysis. Breast Care (Basel). 2020 Aug;15(4):415-420. doi: 10.1159/000503602. Epub 2019 Oct 22.
PubMed 32982653Wang Y, Song J, Tu Y, Chen C, Sun S. Minimally invasive comprehensive treatment for granulomatous lobular mastitis. BMC Surg. 2020 Feb 22;20(1):34. doi: 10.1186/s12893-020-00696-w.
PubMed 32087717
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Combination of Excision and Intraoperative Steroid Administration in Idiopathic Granulomatous Mastitis
- ClinicalTrials.gov ID
- NCT05361629
- Acronym / sponsor ID
- IGM-COMBO / MF 22-02
- Conditions
- Idiopathic Granulomatous Mastitis
- Keywords
- Idiopathic granulomatous mastitis, Steroid injection, Topical steroid, Steroid injection to surgical cavity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 16 Apr 2022 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 May 2022 (actual)
- 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.
After breast cancer, diopathic Granulomatous Mastitis (IGM) is among the breast diseases that bother patients and clinicians the most. Countries with a coast to the Mediterranean, especially our country, are the most common geography of this disease. For this reason, a significant part of the important scientific publications about IGM in the last 3-4 decades are from the countries of this geography and mainly from our country. The paradigm of whether IGM should be treated medically or surgically is still a matter of debate. Today, effective treatment results can be achieved with medical treatments, and local drug applications are finding an increasing application area in order to reduce the systemic drug level due to the side effects often seen in this process. As in the centers dealing with breast diseases intensively in our country, patients are treated in our center both by systemic and local means.
Within the body of the Turkish Breast Diseases Federation, after the plans made with the employees of the leading breast centers of the International Breast Health Working Group International planned to start a recording study to observe the activity between, local treatment in the lesion without surgical treatment with systemic treatment in IGM treatment and local treatment together with surgical treatment.
Detailed description
AIM:
Primary: The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on the shortening of the recovery period in Idiopathic Granulomatous Mastitis.
Secondary: Comparison of the side effects and the relationship between the treatment method and the serum cortisol level in patients treated with intralesional steroid + low dose oral steroid and topical steroid
THE WORK PLAN:
A prospective registry study was designed to compare the effectiveness of the combination of intralesional steroid administration used in the treatment of IGM + low-dose oral steroid therapy used together with the combination of surgical excision and intraoperative intra-cavity steroid administration.
For this purpose, it was planned to observe treatment success rates, time to treatment, recurrence rates at the earliest 1 year follow-up, and side effects related to surgical oral steroid use in eligible IGM patients treated in two different treatment groups.
METHOD:
After clinical and radiological evaluation, histopathological examination will be performed from core biopsy samples taken under ultrasound guidance and tuberculosis (TB) PCR and microbiological culture evaluation will be performed in all patients to rule out specific granulomatous inflammation. Patients with granulmatous inflammation characterized by histopathologically noncaseating granulomas, TB PCR negative and without culture growth, who meet the inclusion criteria, will be recruited into one of the two main treatment arms, at the discretion of the treating centre. There will be no randomization in determining the method of treatment. The type of treatment will be chosen according to the facilities of the performing center, especially the availability of intermittent access to the hospital for non-surgical treatment, and the priority to be determined between the patient and the physician. Since the efficiency superiority between the two methods is not known, any one will not be prioritized and the choice of treatment method will be determined by the patient and the physician. Among these patients, in those with localized abscess type IGM, the abscess foci that are present at the stage of sampling for TB PCR, microbiology culture and histopathology evaluation will be completely aspirated before the treatment is started, and will be waited until the sample results are obtained.
Treatment arms:
Group 1 (NON-SURGERY GROUP): Intralesional steroid + Low dose oral steroid (<30 mg/day prednol) Group 2 (SURGERY GROUP): Excision + Intraoperative steroid injection
Group 1: Patients whose serum cortisol level was observed before starting the treatment, who were injected with 40 mg of prednol at 4 weeks intervals for 3 months for each lesion. The total monthly dose will not exceed 120 mg, and the total 3-month dose will not exceed 200 mg. In this group of patients, the serum cortisol level should have reappeared on the 2nd or 3rd day following each intralesional administration. In this group of patients, low-dose oral prednol (<30 mg/day) and/or topical prednol cream can be applied twice a day during the treatment.
In patients included in Group 2, serum cortisol levels should have been observed before starting treatment. Then the patients should be operated and the mass(s) should be excised. Intraoperatively, not less than 40 mg of prednol should be injected into each mass cavity (it may vary according to the cavity diameter), and the amount applied to all cavities should not exceed 200 mg in total. The amount of prednol administered for each cavity should be recorded. In this group of patients, prednol may have been administered to the cavity walls (Group 2a) or inside the cavity (Group 2b). Serum cortisol levels should be seen in patients 7 to 10 days after the procedure.
Group 2a: 4 Quadrants 40 mg predmol per cavity wall (for < 2 cm lesion and an additional 20 mg for each additional 1 cm) Group 2b: 40 mg predmol into the cavity (for < 2 cm lesion and an additional 20 mg for each additional 1 cm)
Monitoring parameters:
- Recovery rates
- Time to recovery
- Recurrence rates after one-year follow-up
- Complications / side effects due to surgery or oral steroid use
- Relationship between steroid administration method and serum cortisol level Recovery (remission) was defined as the complete disappearance of pre-treatment clinical and ultrasonographic mastitis findings for patients in Group 1, and completion of wound healing for patients in Group 2.
Relapse was defined as the clinical or ultrasonographic re-detection of the disease in the same breast in both groups, following remission, in a similar or different type to the pre-treatment. Any need for repetitive surgery in the surgical arm will also be considered a recurrence.
In case of relapse in patients in both groups, the continuation of treatment will be left to the choice of centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NON-SURGERY GROUP | Active comparator | Procedure: Intralesional steroid administrationGroup 1: Patients whose serum cortisol level was observed before starting the treatment, who were injected with 40 mg of prednol at 4 weeks intervals for 3 months for each lesion. The total monthly dose will not exceed 120 mg, and the total 3-month dose will not exceed 200 mg. In this group of patients, the serum cortisol level should have reappeared on the 2nd or 3rd day following each intralesional administration. In this group of patients, low-dose oral prednol (<30 mg/day) and/or topical prednol cream can be applied twice a day during the treatment. |
| SURGERY GROUP | Active comparator | Procedure: Intraoperative cavity steroid administrationIn patients included in Group 2, serum cortisol levels should have been observed before starting treatment. Then the patients should be operated and the mass(s) should be excised. Intraoperatively, not less than 40 mg of prednol should be injected into each mass cavity (it may vary according to the cavity diameter), and the amount applied to all cavities should not exceed 200 mg in total. The amount of prednol administered for each cavity should be recorded. In this group of patients, prednol may have been administered to the cavity walls (Group 2a) or inside the cavity (Group 2b). Serum cortisol levels should be seen in patients 7 to 10 days after the procedure. Group 2a: 4 Quadrants 40 mg predmol per cavity wall (for < 2cm lesion and an additional 20 mg for each additional 1 cm) Group 2b: 40 mg predmol into the cavity (for < 2 cm lesion and an additional 20 mg for each additional 1 cm) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with IGM histopathologically
- Patients in groups A, B and C according to clinical classification
- Ultrasonographically; Patients with leaf-like hypoechoic type, localized abscess type, and localized hypoechoic mass type mastitis
Key exclusion criteria (6 listed)
- Patients diagnosed with tumor after biopsy
- Those with TB PCR (+)
- Presence of clinically widespread abscess and cellulite (group D patients)
- Ultrasonographically; diffuse diffuse type
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intralesional steroid administrationTreatment by administering steroids into the lesion | Procedure or surgery | NON-SURGERY GROUP |
| Intraoperative cavity steroid administrationTreatment by administering steroids into the surgical cavity | Procedure or surgery | SURGERY GROUP |
Primary outcome
The effect of excision and intraoperative steroid administration to the cavity in Idiopathic Granulomatous Mastitis.
Time frame: one year
The effect of the combination of excision and single dose intraoperative steroid administration to the cavity on outcome in Idiopathic Granulomatous Mastitis.
2 secondary outcomes
Rate of side effects in patients who received intralesional steroid
Time frame: one year
Correlation of treatment modality and serum cortisol levels.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Results publication: PubMed 33039992Hu T, Li S, Huang H, Huang H, Tan L, Chen Y, Deng H, Wu J, Zhu L, Zhang J, Su F, Chen K. Multicentre, randomised, open-label, non-inferiority trial comparing the effectiveness and safety of ductal lavage versus oral corticosteroids for idiopathic granulomatous mastitis: a study protocol. BMJ Open. 2020 Oct 10;10(10):e036643. doi: 10.1136/bmjopen-2019-036643.
- Results publication: PubMed 32231499Ma X, Min X, Yao C. Different Treatments for Granulomatous Lobular Mastitis: A Systematic Review and Meta-Analysis. Breast Care (Basel). 2020 Feb;15(1):60-66. doi: 10.1159/000501498. Epub 2019 Jul 10.
- Results publication: PubMed 32982653Zhou F, Liu L, Liu L, Yu L, Wang F, Xiang Y, Zheng C, Huang S, Cai H, Yu Z. Comparison of Conservative versus Surgical Treatment Protocols in Treating Idiopathic Granulomatous Mastitis: A Meta-Analysis. Breast Care (Basel). 2020 Aug;15(4):415-420. doi: 10.1159/000503602. Epub 2019 Oct 22.
- Results publication: PubMed 32087717Wang Y, Song J, Tu Y, Chen C, Sun S. Minimally invasive comprehensive treatment for granulomatous lobular mastitis. BMC Surg. 2020 Feb 22;20(1):34. doi: 10.1186/s12893-020-00696-w.
- Individual participant dataSharing planned: No
Related trials for Idiopathic Granulomatous Mastitis
RecruitingObservational study
GRAnulomatous MAstitis REGistry Study
Idiopathic Granulomatous Mastitis, Granulomatous Mastitis
Not yet recruitingPhase 1
Steroid Injection in Idiopathic Granulomatous Mastitis
Idiopathic Granulomatous Mastitis
Not yet recruitingPhase 4
Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease
Idiopathic Granulomatous Mastitis
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.
Ozgur Aytac, MD study director
Baskent University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intralesional steroid administration and Intraoperative cavity steroid administration in people with Idiopathic Granulomatous Mastitis, run by Baskent University at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 May 2022. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ozgur Aytac, MD (905326529343, oaytac@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of excision and intraoperative steroid administration to the cavity in Idiopathic Granulomatous Mastitis. (time frame: one year). 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 NCT05361629, which also lists 4 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 5 May 2022; AzTrials last refreshed its copy on 1 Nov 2026.