An observational study in Granulomatous Mastitis, sponsored by First Affiliated Hospital of Harbin Medical University. Status unknown at 1 site in China. Open to female participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-08-22.
Sponsored by First Affiliated Hospital of Harbin Medical University · Observational
Among 10 studies in Granulomatous Mastitis with a site in China — 2 open to participants now, 3 under way, none of them phase 3. Granulomatous Mastitis · China.
Among the 10 studies in Granulomatous Mastitis with a site in China, this one is one of 4 that started in 2024, is one of 4 observational ones, and was the 7th registered.
22 studies on the registry are indexed under Granulomatous Mastitis; 7 are open to participants now.
Browse Granulomatous Mastitis studies →2 of the 10 studies in Granulomatous Mastitis with a site in China are open now. Recruiting first, the newest first:
Hubei Cancer Hospital · Sites in China
Ages 18+ · Women only
Wuhan University · Sites in China
Ages 18–60 · Women only
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 2 Granulomatous Mastitis studies recruiting now, 2 set no upper age limit and none stop at 75 or younger; none take children under 18; none take healthy volunteers.
This study: 15 Years to 65 Years · female.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
10 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 4 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 350 is above the median of 79 across 10 observational studies indexed under Granulomatous Mastitis.
Median enrollment 100 across the 6 interventional studies, 210 across the 4 observational. Of the 3 that completed or were terminated, 0 (0%) have results posted.
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None of the 10 has an industry lead sponsor. The 6 most frequent:
First Affiliated Hospital of Harbin Medical University is the lead sponsor of 74 studies on the registry; 11 are open to participants now.
First Affiliated Hospital of Harbin Medical University has 2 studies filed under Granulomatous Mastitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Granulomatous Mastitis with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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.
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Exclusion Criteria:
The patients underwent surgery
Procedure: Surgery
The patients were treated with triple anti-tuberculosis drugs
Drug: triple anti-tuberculosis drug
The patients were treated with surgery first, and then took triple anti-tuberculosis drugs after surgery
Procedure: Surgery · Drug: triple anti-tuberculosis drug
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.
Patients took oral rifampin (450 mg/day), isoniazid (300 mg/day), and ethambutol (15 mg/kg/day).
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline
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.
Time frame: 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.
Time frame: Baseline
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Sep 2024, 1 month after the start.
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This study is status unknown, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital of Harbin Medical University