NCT07422870Recruiting
GRAnulomatous MAstitis REGistry Study
A Retrospective / Prospective Cohort Study to Evaluate the Incidence, Diagnostic Features, Clinical Course and Treatment Strategies in Histologically Confirmed Idiopathic Granulomatous Mastitis
Source: ClinicalTrials.gov · Last updated 15 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 13 Feb 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Apr 2031
- Lead sponsor
- European Breast Cancer Research Association of Surgical Trialists
- NCT number
- NCT07422870
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 1 Jul 2026 to the primary completion date, 1 Apr 2031
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Tuberculosis, Sarcoidosis, Fungal infection, Parasitic infection, Foreign body reaction
Other
- Patients with suspicion of idiopathic granulomatous mastitis but without histological confirmation
- Suspicion of OR confirmed secondary granulomatous mastitis due to:
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Düsseldorf Coordinator of this site? Confirm its status | Düsseldorf | Germany | Recruiting |
| Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein Coordinator of this site? Confirm its status | Lübeck | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.