[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625456":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":46,"studyPopulation":47,"armGroups":48,"interventions":42,"overallOfficials":42,"centralContacts":52,"locations":58,"responsibleParty":90,"collaborators":42,"id":92,"slug":42,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":93,"sex":99,"minAge":100,"maxAge":42,"enrollmentInfo":101,"targetDuration":104,"studyType":105,"phases":42,"briefSummary":106,"conditions":107,"keywords":110,"overallStatus":124,"whyStopped":42,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"European Breast Cancer Research Association of Surgical Trialists","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":42},[9,13],{"measure":10,"description":11,"timeFrame":12},"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","At initial diagnosis (baseline)",{"measure":14,"description":15,"timeFrame":16},"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)","From initial diagnosis through symptom resolution, up to 5 years",[18,22,26,30,34,38],{"measure":19,"description":20,"timeFrame":21},"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","From initial diagnosis through completion of treatment, up to 5 years",{"measure":23,"description":24,"timeFrame":25},"Number of Surgeries Performed","Total number of surgical procedures (incision, drainage, excision, mastectomy) required per patient","From initial diagnosis through 5 years follow-up",{"measure":27,"description":28,"timeFrame":29},"Recurrence Rate","Proportion of patients experiencing recurrence of idiopathic granulomatous mastitis after initial treatment","At 1, 3, and 5 years after first diagnosis",{"measure":31,"description":32,"timeFrame":33},"Risk Factors Associated with Recurrence","Identification of patient demographics, clinical characteristics, and treatment factors associated with disease recurrence","At 1, 3, and 5 years follow-up",{"measure":35,"description":36,"timeFrame":37},"Time to Histological Confirmation","Time interval in days or weeks between first symptom occurrence and first histological confirmation of idiopathic granulomatous mastitis","At baseline (from retrospective chart review or patient recall)",{"measure":39,"description":40,"timeFrame":41},"Presentation on Breast Imaging","Imaging characteristics on mammography, sonography, and MRI (if performed) as assessed by the International Steering Committee","At initial diagnosis",null,{"allocation":42,"interventionModel":42,"interventionModelDescription":42,"primaryPurpose":42,"observationalModel":44,"timePerspective":45,"maskingInfo":42},"COHORT","OTHER","Background:\n\nIdiopathic 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.\n\nThe 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.\n\nTreatment 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.\n\nStudy Design:\n\nThis is an investigator-initiated non-interventional observational international prospective\u002Fretrospective cohort study with unlimited accrual and open registry duration due to disease rarity.\n\nData Collection Methods:\n\nRetrospective Phase:\n\nCollection and analysis via anonymized electronic database maintained by EUBREAST e.V. Participating Study Sites identify and document patients with histologically confirmed IGM treated between January 1, 2015, and Study Site activation. No patient identifying information is disclosed or documented. Data are fully anonymous without prospective follow-up.\n\nProspective Phase:\n\nPatients with histologically confirmed IGM presenting after Study Site activation are informed about possible participation. Written informed consent is obtained. Diagnostic management and treatment follow institutional standards without protocol deviation. Follow-up occurs at 1, 3, and 5 years after first diagnosis to evaluate current symptoms and document potential recurrence.","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.",[49],{"label":50,"type":42,"description":51,"interventionNames":42},"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.",[53],{"name":54,"role":55,"phone":56,"phoneExt":42,"email":57},"Natalia Krawczyk, PD Dr. med.","CONTACT","+49 0211 0","Natalia.Krawczyk@med.uni-duesseldorf.de",[59,75],{"facility":60,"status":42,"city":61,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"University Hospital Düsseldorf","Düsseldorf","North Rhine-Westphalia","40225","Germany","DE",{"type":67,"coordinates":68},"Point",[69,70],6.77927,51.22319,{"lat":70,"lon":69},[73],{"name":54,"role":55,"phone":74,"phoneExt":42,"email":57},"+49211 81 0",{"facility":76,"status":42,"city":77,"state":78,"zip":79,"country":64,"countryCode":65,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein","Lübeck","Schleswig-Holstein","23562",{"type":67,"coordinates":81},[82,83],10.68729,53.86893,{"lat":83,"lon":82},[86],{"name":87,"role":55,"phone":88,"phoneExt":42,"email":89},"Maggie Banys-Paluchowski, Prof. Dr. med.","+49451 500-41700","Maggie.Banys-Paluchowski@uksh.de",{"type":91,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100625456",false,"NCT07422870","GRAnulomatous MAstitis REGistry Study","A Retrospective \u002F Prospective Cohort Study to Evaluate the Incidence, Diagnostic Features, Clinical Course and Treatment Strategies in Histologically Confirmed Idiopathic Granulomatous Mastitis","GRAMAREG","Inclusion Criteria:\n\n* Histologically confirmed idiopathic granulomatous mastitis OR cystic neutrophilic granulomatous mastitis by local pathology (minimally invasive biopsy or histological confirmation on surgical specimen)\n* First histological confirmation after January 1, 2015\n* Female or male patients ≥18 years old\n* 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)\n\nExclusion Criteria:\n\n* Patients with suspicion of idiopathic granulomatous mastitis but without histological confirmation\n* Suspicion of OR confirmed secondary granulomatous mastitis due to:\n* Tuberculosis, Sarcoidosis, Fungal infection, Parasitic infection, Foreign body reaction","ALL","18 Years",{"count":102,"type":103},1000,"ESTIMATED","5 Years","OBSERVATIONAL","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.\n\nThe GRAMAREG study is the first European registry for patients with histologically confirmed idiopathic granulomatous mastitis. This retrospective\u002Fprospective 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.\n\nAll 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.",[108,109],"Idiopathic Granulomatous Mastitis","Granulomatous Mastitis",[111,112,113,114,115,116,117,118,119,120,121,122,123],"Idiopathic granulomatous mastitis","IGM","Granulomatous mastitis","Cystic neutrophilic granulomatous mastitis","CNGM","Inflammatory breast disease","Benign breast disease","Chronic mastitis","Non-lactational mastitis","Breast inflammation","Patient registry","Cohort study","granulomatous lobular mastitis","NOT_YET_RECRUITING","2026-02-26",{"date":127,"type":128},"2026-02-27","ACTUAL",{"date":130,"type":103},"2026-04-01",{"date":132,"type":103},"2036-04-01",{"name":5,"class":6},2]