[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625456":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":50,"collaborators":10,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":65,"studyType":66,"phases":10,"briefSummary":67,"conditions":68,"keywords":71,"overallStatus":85,"whyStopped":10,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"European Breast Cancer Research Association of Surgical Trialists","NETWORK",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Idiopathic Granulomatous Mastitis Patients",null,"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.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Natalia Krawczyk, PD Dr. med.","CONTACT","+49 0211 0","Natalia.Krawczyk@med.uni-duesseldorf.de",[19,35],{"facility":20,"status":10,"city":21,"state":22,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"University Hospital Düsseldorf","Düsseldorf","North Rhine-Westphalia","40225","Germany","DE",{"type":27,"coordinates":28},"Point",[29,30],6.77927,51.22319,{"lat":30,"lon":29},[33],{"name":14,"role":15,"phone":34,"phoneExt":10,"email":17},"+49211 81 0",{"facility":36,"status":10,"city":37,"state":38,"zip":39,"country":24,"countryCode":25,"cosmosGeoPoint":40,"geoPoint":44,"contacts":45},"Department of Gynecology and Obstetrics University Hospital Schleswig-Holstein","Lübeck","Schleswig-Holstein","23562",{"type":27,"coordinates":41},[42,43],10.68729,53.86893,{"lat":43,"lon":42},[46],{"name":47,"role":15,"phone":48,"phoneExt":10,"email":49},"Maggie Banys-Paluchowski, Prof. Dr. med.","+49451 500-41700","Maggie.Banys-Paluchowski@uksh.de",{"type":51,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100625456","granulomatous-mastitis-registry-study-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":63,"type":64},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.",[69,70],"Idiopathic Granulomatous Mastitis","Granulomatous Mastitis",[72,73,74,75,76,77,78,79,80,81,82,83,84],"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":88,"type":89},"2026-02-27","ACTUAL",{"date":91,"type":64},"2026-04-01",{"date":93,"type":64},"2036-04-01",{"name":5,"class":6},2]