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GRAnulomatous MAstitis REGistry Study

Recruitingn/aAges 18 Years - anyAllEuropean Breast Cancer Research Association of Su…
NCT07422870 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 dat

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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) Exclusion Criteria: * 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
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What it tests

  • Not listed
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Where

2 sites
University Hospital Düsseldorf
Düsseldorf, Germany
Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein
Lübeck, Germany
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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