A Retrospective / Prospective Cohort Study to Evaluate the Incidence, Diagnostic Features, Clinical Course and Treatment Strategies in Histologically Confirmed Idiopathic Granulomatous Mastitis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Proportion of Patients Presenting with Specific Symptoms
研究概览
简要总结
Idiopathic granulomatous mastitis (IGM) is a rare benign inflammatory breast condition with unknown cause, affecting approximately 2.4 per 100,000 women aged 20-40 years. Patients experience severe local symptoms including pain, redness, and recurrent abscesses that can last weeks to months and often mimic inflammatory breast cancer. Due to its rarity, mostly case reports and case series exist in the literature, leading to limited knowledge about risk factors, optimal treatment strategies, and clinical outcomes.
The GRAMAREG study is the first European registry for patients with histologically confirmed idiopathic granulomatous mastitis. This retrospective/prospective observational cohort study aims to systematically evaluate the incidence, diagnostic features, clinical course, treatment strategies, and patient outcomes of this uncommon disease. The study collects both retrospective data (from January 1, 2015 onwards) and prospective data from participating sites across Europe.
All diagnostic and therapeutic procedures are conducted according to institutional standards in clinical routine, as this is a non-interventional study. Patients in the prospective cohort are followed for up to 5 years to document symptom duration and recurrence rates.
详细描述
Background:
Idiopathic granulomatous mastitis was first described by Kessler and Wolloch in 1972. The etiology remains largely unknown due to its rare occurrence. Valid prevalence data in Europe are lacking, though incidence appears higher in low-income countries compared to Western Europe. IGM predominantly occurs in women of childbearing age, mostly parous and more frequently of non-white ethnicity.
The diagnosis is confirmed only by histological evaluation, typically using core needle biopsy. Patients commonly develop recurrent breast abscesses that do not improve with antibacterial medication and often require repeat incisions or drainages. IGM must be differentiated from granulomatous inflammation associated with duct ectasia, foreign material reactions, specific infections (tuberculosis, fungi, parasites), systemic granulomatous diseases (sarcoidosis), and cystic neutrophilic granulomatous mastitis (CNGM) linked to Corynebacterium species.
Treatment strategies described in literature include high-dose steroids, immunosuppressive agents, bromocriptine, antibiotics, surgical resection, or even mastectomy. However, no evidence-based treatment recommendations are currently available.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed idiopathic granulomatous mastitis OR cystic neutrophilic granulomatous mastitis by local pathology (minimally invasive biopsy or histological confirmation on surgical specimen)
- •First histological confirmation after January 1, 2015
- •Female or male patients ≥18 years old
- •Signed informed consent form for all patients included in prospective part of the study (patients presenting with idiopathic granulomatous mastitis after activation of the study at Study Site)
排除标准
- •Patients with suspicion of idiopathic granulomatous mastitis but without histological confirmation
- •Suspicion of OR confirmed secondary granulomatous mastitis due to:
- •Tuberculosis, Sarcoidosis, Fungal infection, Parasitic infection, Foreign body reaction
研究组 & 干预措施
Idiopathic Granulomatous Mastitis Patients
Female and male patients ≥18 years old with histologically confirmed idiopathic granulomatous mastitis (IGM) or cystic neutrophilic granulomatous mastitis (CNGM) diagnosed after January 1, 2015. Histological confirmation obtained by minimally invasive biopsy or on surgical specimen by local pathology. Excludes patients with secondary granulomatous mastitis due to tuberculosis, sarcoidosis, fungal and parasitic infection, or foreign body.
结局指标
主要结局
Proportion of Patients Presenting with Specific Symptoms
时间窗: At initial diagnosis (baseline)
Percentage of patients presenting with specific clinical symptoms including pain, redness, and palpable breast mass at initial presentation
Duration of Symptoms Depending on Treatment Strategy
时间窗: From initial diagnosis through symptom resolution, up to 5 years
Time from initial symptom onset to symptom resolution measured in weeks or months, stratified by treatment approach (systemic treatment, surgical intervention, conservative management)
次要结局
- Type and Duration of Systemic Treatment(From initial diagnosis through completion of treatment, up to 5 years)
- Number of Surgeries Performed(From initial diagnosis through 5 years follow-up)
- Recurrence Rate(At 1, 3, and 5 years after first diagnosis)
- Risk Factors Associated with Recurrence(At 1, 3, and 5 years follow-up)
- Time to Histological Confirmation(At baseline (from retrospective chart review or patient recall))
- Presentation on Breast Imaging(At initial diagnosis)