GRAnulomatous MAstitis REGistry Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuropean Breast Cancer Research Association of Surgical Trialists
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Patients with suspicion of idiopathic granulomatous mastitis but without histological confirmation
Tuberculosis, Sarcoidosis, Fungal infection, Parasitic infection, Foreign body reaction
Trial population
Patients diagnosed with histologically confirmed idiopathic granulomatous mastitis (IGM) or cystic neutrophilic granulomatous mastitis (CNGM) at participating European breast centers and hospitals. The population includes both retrospectively identified patients (diagnosed January 1, 2015, through Study Site activation) and prospectively enrolled patients (diagnosed after Study Site activation). IGM predominantly affects women of childbearing age, mostly parous, and more frequently of non-white ethnicity, though both males and females ≥18 years are eligible.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
1,000 Participants
are grouped into 1 trial groupGroup A: Idiopathic Granulomatous Mastitis Patients
Trial outcomes
Primary outcomes
1
Proportion of Patients Presenting with Specific Symptoms
Percentage of patients presenting with specific clinical symptoms including pain, redness, and palpable breast mass at initial presentation
Time frame
At initial diagnosis (baseline)2
Duration of Symptoms Depending on Treatment Strategy
Time from initial symptom onset to symptom resolution measured in weeks or months, stratified by treatment approach (systemic treatment, surgical intervention, conservative management)
Time frame
From initial diagnosis through symptom resolution, up to 5 yearsSecondary outcomes
1
Type and Duration of Systemic Treatment
Specific systemic treatments received (e.g., corticosteroids, immunosuppressive agents, antibiotics) and duration of each treatment in weeks or months
Time frame
From initial diagnosis through completion of treatment, up to 5 years2
Number of Surgeries Performed
Total number of surgical procedures (incision, drainage, excision, mastectomy) required per patient
Time frame
From initial diagnosis through 5 years follow-up3
Recurrence Rate
Proportion of patients experiencing recurrence of idiopathic granulomatous mastitis after initial treatment
Time frame
At 1, 3, and 5 years after first diagnosis4
Risk Factors Associated with Recurrence
Identification of patient demographics, clinical characteristics, and treatment factors associated with disease recurrence
Time frame
At 1, 3, and 5 years follow-upSponsors and contacts
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Source ClinicalTrials.gov