Granulomatous MastitisNCT06565845
Analysis of Various Treatment Methods of Granulomatous Lobular Mastitis
An observational study of Granulomatous Mastitis, run by First Affiliated Hospital of Harbin Medical University at 1 site in China.
Trial summary
Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. Read more about this study
- Who is it for?
- Ages 15 to 65 years, women only
- Conditions the study is for
- Granulomatous Mastitis
- What is being tested?
- Surgery and triple anti-tuberculosis drug
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 19 Aug 2024to 19 Oct 2024
- 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 15 to 65 years
- Women only
- Child, Adult, Older adult
Study population: Female patients with GLM who were treated at the Breast Surgery Department of the First Affiliated Hospital of Harbin Medical University were selected.Patients with GLM mostly present with unilateral disease, and the lesions can be located in any part of the breast. Arthritis and lower limb erythema nodosum are rare.
Who may be able to join
- non-lactating and aged 15-65 years
- histopathological confirmation of GLM
- normal liver and kidney function
Who cannot join
- lactating and pregnant women
- allergies to rifampin, isoniazid, or ethambutol
- concurrent malignant breast tumors
- severe underlying diseases
- other conditions deemed unsuitable by the investigator and
- refusal to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First affiliated hospital of Harbin medical university
Harbin, Heilongjiang, 150001
Yi Zhou, +86-0451-85552102, lubj2001@163.com
About this study
Official title: Analysis of the Clinical Characteristics and Three Treatment Methods of Granulomatous Lobular Mastitis
Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.
Read the detailed description
In recent years, the incidence of this disease has been increasing annually. The incidence of GLM is region-specific, being higher in Mediterranean regions and Asian countries. The etiology is currently unclear, but many studies suggest that GLM is associated with autoimmune disorders, hormonal imbalances, and microbial infections . GLM has a long course, is difficult to treat, and prone to recurrence, causing significant trauma to the patient's breast appearance and overall well-being. Currently, the main treatment methods for GLM include surgical treatment, drug therapy, combined surgery with drug therapy, and close observation. Surgical treatment options mainly include abscess incision and drainage, segmental resection, subcutaneous mastectomy, mastectomy, and breast reconstruction. Although surgical treatment can rapidly improve the condition, the recurrence rate reported in the literature ranges from 5% to 50% . Although GLM is a benign disease, it can severely impact the patient's normal life, causing physical and psychological trauma. However, few studies have included patients' subjective treatment experiences in the evaluation of treatment outcomes.
To date, there have been no studies comparing the efficacy of three treatment methods (surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy) in the same population of GLM patients. This study aims to compare the efficacy and patient satisfaction of these three treatment methods, with the hope of providing new insights for clinical treatment options.
- Conditions
- Granulomatous Mastitis
- Being tested
- Surgery, triple anti-tuberculosis drug
- Keywords
- Granulomatous lobular mastitis, surgical treatment, antituberculosis therapy, surgery combined with anti-tuberculosis therapy
- Medical subject headings
- Granulomatous Mastitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
patients underwent complete excision of the inflammatory breast tissue and some surrounding normal tissue under combined intravenous with inhalation anesthesia. Damaged skin was also removed.
triple anti-tuberculosis drugDrug
Patients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day).
| Study group | Role | What they receive |
|---|---|---|
| surgery group | The patients underwent surgery Receives: Procedure: Surgery | |
| triple anti-tuberculosis drug therapy group | The patients were treated with triple anti-tuberculosis drugs Receives: Drug: triple anti-tuberculosis drug | |
| combination therapy group | The patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery Receives: Procedure: Surgery; Drug: triple anti-tuberculosis drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the cure rate of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The cure rate was compared among the three groups.
Measured: Baseline
Differences in the recurrence rate of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The recurrence rate was compared among the three groups.
Measured: Baseline
Differences in the incidence of adverse reactions of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The incidence of adverse reactions was compared among the three groups.
Measured: Baseline
Secondary outcomes (2)
Differences in the patient satisfaction score (points) of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The patient satisfaction score (points) was compared among the three groups.
Measured: Baseline
Differences in the treatment duration (months) of the three treatment modalities
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The treatment duration (months) was compared among the three groups.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start19 Aug 2024
- Primary completion19 Sep 2024 (estimated)
- Study completion19 Oct 2024 (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 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Harbin Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jing Feng, Study director, First Affiliated Hospital of Harbin Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06565845
- Sponsor's protocol ID
- 2024182
- Status last verified
- Aug 2024
- First submitted
- 18 Aug 2024
- Last updated
- 22 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kessler E, Wolloch Y. Granulomatous mastitis: a lesion clinically simulating carcinoma. Am J Clin Pathol. 1972 Dec;58(6):642-6. doi: 10.1093/ajcp/58.6.642. No abstract available.
PubMed 4674439Yuan QQ, Xiao SY, Farouk O, Du YT, Sheybani F, Tan QT, Akbulut S, Cetin K, Alikhassi A, Yaghan RJ, Durur-Subasi I, Altintoprak F, Eom TI, Alper F, Hasbahceci M, Martinez-Ramos D, Oztekin PS, Kwong A, Pluguez-Turull CW, Brownson KE, Chandanwale S, Habibi M, Lan LY, Zhou R, Zeng XT, Bai J, Bai JW, Chen QR, Chen X, Zha XM, Dai WJ, Dai ZJ, Feng QY, Gao QJ, Gao RF, Han BS, Hou JX, Hou W, Liao HY, Luo H, Liu ZR, Lu JH, Luo B, Ma XP, Qian J, Qin JY, Wei W, Wei G, Xu LY, Xue HC, Yang HW, Yang WG, Zhang CJ, Zhang F, Zhang GX, Zhang SK, Zhang SQ, Zhang YQ, Zhang YP, Zhang SC, Zhao DW, Zheng XM, Zheng LW, Xu GR, Zhou WB, Wu GS. Correction: Management of granulomatous lobular mastitis: an international multidisciplinary consensus (2021 edition). Mil Med Res. 2022 Aug 23;9(1):47. doi: 10.1186/s40779-022-00408-w. No abstract available.
PubMed 35999646Akcan A, Akyildiz H, Deneme MA, Akgun H, Aritas Y. Granulomatous lobular mastitis: a complex diagnostic and therapeutic problem. World J Surg. 2006 Aug;30(8):1403-9. doi: 10.1007/s00268-005-0476-0.
PubMed 16847715Shang B, Zhang T, Liu C, Lu J, Cui C, Feng J, Zhou Y. Analysis of three treatment methods for granulomatous lobular mastitis: a retrospective study in a single center. Front Oncol. 2025 Apr 30;15:1588836. doi: 10.3389/fonc.2025.1588836. eCollection 2025.
PubMed 40371221
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Clinical Characteristics and Three Treatment Methods of Granulomatous Lobular Mastitis
- ClinicalTrials.gov ID
- NCT06565845
- Acronym / sponsor ID
- 2024182
- Conditions
- Granulomatous Mastitis
- Keywords
- Granulomatous lobular mastitis, surgical treatment, antituberculosis therapy, surgery combined with anti-tuberculosis therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Harbin Medical UniversityUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- 19 Sep 2024 (estimated)
- Study completion
- 19 Oct 2024 (estimated)
- First posted
- 22 Aug 2024 (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.
Granulomatous lobular mastitis (GLM) is a rare benign breast disease that is difficult to distinguish from breast cancer based on clinical and imaging findings, and there is currently no standard treatment. This study aims to analyze the clinical characteristics and demographic data of GLM patients and to compare the overall effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy, with the goal of providing new insights for clinical treatment.
Detailed description
In recent years, the incidence of this disease has been increasing annually. The incidence of GLM is region-specific, being higher in Mediterranean regions and Asian countries. The etiology is currently unclear, but many studies suggest that GLM is associated with autoimmune disorders, hormonal imbalances, and microbial infections . GLM has a long course, is difficult to treat, and prone to recurrence, causing significant trauma to the patient's breast appearance and overall well-being. Currently, the main treatment methods for GLM include surgical treatment, drug therapy, combined surgery with drug therapy, and close observation. Surgical treatment options mainly include abscess incision and drainage, segmental resection, subcutaneous mastectomy, mastectomy, and breast reconstruction. Although surgical treatment can rapidly improve the condition, the recurrence rate reported in the literature ranges from 5% to 50% . Although GLM is a benign disease, it can severely impact the patient's normal life, causing physical and psychological trauma. However, few studies have included patients' subjective treatment experiences in the evaluation of treatment outcomes.
To date, there have been no studies comparing the efficacy of three treatment methods (surgery alone, triple anti-tuberculosis drug therapy alone, and combined surgery with triple anti-tuberculosis drug therapy) in the same population of GLM patients. This study aims to compare the efficacy and patient satisfaction of these three treatment methods, with the hope of providing new insights for clinical treatment options.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| surgery group | – | Procedure: SurgeryThe patients underwent surgery |
| triple anti-tuberculosis drug therapy group | – | Drug: triple anti-tuberculosis drugThe patients were treated with triple anti-tuberculosis drugs |
| combination therapy group | – | Procedure: Surgery, Drug: triple anti-tuberculosis drugThe patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery |
Who may qualify
- Ages
- 15 to 65 years
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- Female patients with GLM who were treated at the Breast Surgery Department of the First Affiliated Hospital of Harbin Medical University were selected.Patients with GLM mostly present with unilateral disease, and the lesions can be located in any part of the breast. Arthritis and lower limb erythema nodosum are rare.
Key inclusion criteria (3 listed)
- non-lactating and aged 15-65 years
- histopathological confirmation of GLM
- normal liver and kidney function
Key exclusion criteria (6 listed)
- lactating and pregnant women
- allergies to rifampin, isoniazid, or ethambutol
- concurrent malignant breast tumors
- severe underlying diseases
- other conditions deemed unsuitable by the investigator and
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 |
|---|---|---|
| Surgerypatients underwent complete excision of the inflammatory breast tissue and some surrounding normal tissue under combined intravenous with inhalation anesthesia. Damaged skin was also removed. | Procedure or surgery | combination therapy group, surgery group |
| triple anti-tuberculosis drugPatients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day). | Drug | combination therapy group, triple anti-tuberculosis drug therapy group |
Primary outcome
Differences in the cure rate of the three treatment modalities
Time frame: Baseline
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The cure rate was compared among the three groups.
Differences in the recurrence rate of the three treatment modalities
Time frame: Baseline
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The recurrence rate was compared among the three groups.
Differences in the incidence of adverse reactions of the three treatment modalities
Time frame: Baseline
According to the treatment method, the patients were divided into three groups: surgery group, triple anti-TB drug treatment group, and combination treatment group. IBM SPSS 27.0 software was used for statistical analysis. The incidence of adverse reactions was compared among the three groups.
2 secondary outcomes
Differences in the patient satisfaction score (points) of the three treatment modalities
Time frame: Baseline
Differences in the treatment duration (months) of the three treatment modalities
Time frame: Baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2024.
- Background: PubMed 4674439Kessler E, Wolloch Y. Granulomatous mastitis: a lesion clinically simulating carcinoma. Am J Clin Pathol. 1972 Dec;58(6):642-6. doi: 10.1093/ajcp/58.6.642. No abstract available.
- Background: PubMed 35999646Yuan QQ, Xiao SY, Farouk O, Du YT, Sheybani F, Tan QT, Akbulut S, Cetin K, Alikhassi A, Yaghan RJ, Durur-Subasi I, Altintoprak F, Eom TI, Alper F, Hasbahceci M, Martinez-Ramos D, Oztekin PS, Kwong A, Pluguez-Turull CW, Brownson KE, Chandanwale S, Habibi M, Lan LY, Zhou R, Zeng XT, Bai J, Bai JW, Chen QR, Chen X, Zha XM, Dai WJ, Dai ZJ, Feng QY, Gao QJ, Gao RF, Han BS, Hou JX, Hou W, Liao HY, Luo H, Liu ZR, Lu JH, Luo B, Ma XP, Qian J, Qin JY, Wei W, Wei G, Xu LY, Xue HC, Yang HW, Yang WG, Zhang CJ, Zhang F, Zhang GX, Zhang SK, Zhang SQ, Zhang YQ, Zhang YP, Zhang SC, Zhao DW, Zheng XM, Zheng LW, Xu GR, Zhou WB, Wu GS. Correction: Management of granulomatous lobular mastitis: an international multidisciplinary consensus (2021 edition). Mil Med Res. 2022 Aug 23;9(1):47. doi: 10.1186/s40779-022-00408-w. No abstract available.
- Background: PubMed 16847715Akcan A, Akyildiz H, Deneme MA, Akgun H, Aritas Y. Granulomatous lobular mastitis: a complex diagnostic and therapeutic problem. World J Surg. 2006 Aug;30(8):1403-9. doi: 10.1007/s00268-005-0476-0.
- Derived from this study: PubMed 40371221Shang B, Zhang T, Liu C, Lu J, Cui C, Feng J, Zhou Y. Analysis of three treatment methods for granulomatous lobular mastitis: a retrospective study in a single center. Front Oncol. 2025 Apr 30;15:1588836. doi: 10.3389/fonc.2025.1588836. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Jing Feng study director
First Affiliated Hospital of Harbin Medical University
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 First Affiliated Hospital of Harbin Medical University at 1 site in China.
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 22 Aug 2024. 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 China. 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 Yi Zhou (+86-0451-85552102, lubj2001@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the cure rate of the three treatment modalities (time frame: Baseline). The study lists 3 primary outcomes in all. 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 NCT06565845, 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 22 Aug 2024.