GRAnulomatous MAstitis REGistry Study

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Conditions studied: Idiopathic Granulomatous Mastitis, Granulomatous Mastitis

In brief

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.

Key facts

Study ID

NCT07422870

Run by

European Breast Cancer Research Association of Surgical Trialists

People needed

1000

Starts

2026-04-01

Expected to finish

2036-04-01

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• University Hospital Düsseldorf — Düsseldorf, North Rhine-Westphalia, Germany
• Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein — Lübeck, Schleswig-Holstein, Germany

Full record on ClinicalTrials.gov

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