Analyzing treatment methods for granulomatous lobular mastitis
Analysis of the Clinical Characteristics and Three Treatment Methods of Granulomatous Lobular Mastitis
This study is trying to see which treatment works best for people with granulomatous lobular mastitis by comparing surgery, medication, or a mix of both.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 15 Years to 65 Years |
| Sex | Female |
| Sponsor | First Affiliated Hospital of Harbin Medical University Academic / other |
| Locations | 1 site (Harbin, Heilongjiang) |
| Trial ID | NCT06565845 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on granulomatous lobular mastitis (GLM), a rare benign breast condition that can mimic breast cancer. It aims to analyze the clinical characteristics and demographic data of GLM patients while comparing the effectiveness of three treatment methods: surgery alone, triple anti-tuberculosis drug therapy alone, and a combination of both. The study seeks to provide insights into treatment efficacy and patient satisfaction, addressing the lack of standard treatment protocols for this condition. By evaluating these methods, the research hopes to improve clinical outcomes for patients suffering from GLM.
Who should consider this trial
Good fit: Ideal candidates for this study are non-lactating women aged 15-65 years with histopathologically confirmed granulomatous lobular mastitis.
Not a fit: Patients who are lactating, pregnant, or have concurrent malignant breast tumors will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment options for patients with granulomatous lobular mastitis.
How similar studies have performed: There have been no prior studies comparing these specific treatment methods in the same population of GLM patients, making this approach novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * non-lactating and aged 15-65 years * histopathological confirmation of GLM * normal liver and kidney function Exclusion Criteria: * 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
Where this trial is running
Harbin, Heilongjiang
- First affiliated hospital of Harbin medical university — Harbin, Heilongjiang, China (Recruiting)
Study contacts
- Study coordinator: Yi Zhou
- Email: lubj2001@163.com
- Phone: +86-0451-85552102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.