[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-granulomatous-mastitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-granulomatous-mastitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,55,84],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"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":20,"type":21},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.",[26,27],"Idiopathic Granulomatous Mastitis","Granulomatous Mastitis",[29,30,31,32,33,34,35,36,37,38,39,40,41],"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":45,"type":46},"2026-02-27","ACTUAL",{"date":48,"type":21},"2026-04-01",{"date":50,"type":21},"2036-04-01",{"name":52,"class":53},"European Breast Cancer Research Association of Surgical Trialists","NETWORK",2,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":62,"minAge":18,"maxAge":63,"enrollmentInfo":64,"targetDuration":4,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":71,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100591831","phase-1-steroid-injection-in-idiopathic-granulomatous-mastitis-100591831","NCT06985537","Steroid Injection in Idiopathic Granulomatous Mastitis","Efficacy of Ultrasound Guided Intralesional Steroid Injection in Idiopathic Granulomatous Mastitis (IGM)","Inclusion Criteria:\n\n* Women diagnosed with IGM confirmed clinically and histopathologically , willing to undergo intralesional steroid treatment.\n\nExclusion Criteria:\n\n* Patients with active infections.\n* Patients on immunosuppressive therapy.\n* pregnant women.","FEMALE","45 Years",{"count":65,"type":21},40,"INTERVENTIONAL",[68],"PHASE1","Granulomatous mastitis (GM) is a non-infectious inflammatory breast condition typically affecting young women, often following breastfeeding. Management of GM often begins with anti-inflammatory medications and antibiotics. Steroids, particularly intralesional corticosteroids, are considered the first-line treatment for GM due to their rapid anti-inflammatory and immunosuppressive effects. Steroids help control symptoms such as painful lumps, swelling, and redness. Steroids' effectiveness in providing symptom relief minimizes the need for more invasive treatments such as surgery.",[26],[72,73],"Idiopathic GM","intralesional steroid injection","2025-05-21",{"date":76,"type":46},"2025-05-22",{"date":78,"type":21},"2025-06",{"date":80,"type":21},"2026-02",{"name":82,"class":83},"Assiut University","OTHER",{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":30,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":62,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":66,"phases":94,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":114},"100588598","phase-4-comparing-effectiveness-of-steroids-and-methotrexate-in-treatment-of-chronic-inflammatory-breast-disease-100588598","NCT06943482","Comparing Effectiveness of Steroids and Methotrexate in Treatment of Chronic Inflammatory Breast Disease","A Pilot Open-label Randomised Trial Comparing the Effectiveness of Steroids and Methotrexate for the Treatment of Idiopathic Granulomatous Mastitis","Inclusion Criteria:\n\n* Women, aged between 21 and 60 years\n* Positive diagnosis of idiopathic granulomatous mastitis based on histopathology results\n* Willing and able to give informed consent\n\nExclusion Criteria (Patients who meet any of the following prerequisites will not be allowed to take part in this study):\n\n* Women who are currently pregnant or breastfeeding\n* Cognitive impairment which prevents the patient from giving voluntary consent\n* History of any psychiatric conditions such as depression, psychosis, schizophrenia etc.\n* History of cancer in the past 5 years\n* History of abnormal renal or liver function\n* History of diabetes mellitus\n* History of pulmonary lung disease, pneumonitis, or related conditions\n* Hepatitis B and\u002For Hepatitis C carrier\n* Diagnosed with tuberculosis (Positive microbiological evaluation for Grocott Methenamine Silver stain and Ziehl- Neelsen stain)\n* Any immunosuppressants or anti-inflammatory medications such as NSAIDS for the past 3 months\n* Concomitant medication that may have contraindication with prednisolone and methotrexate use\n* Hypersensitivity to components or drug products of prednisolone and methotrexate\n* Vaccination with live virus vaccines prior to or during treatment","21 Years","60 Years",{"count":65,"type":21},[95],"PHASE4","This research study is to determine the effectiveness of prednisolone and methotrexate for IGM patients over a period of one year, in terms of clinical and radiological response. Recruitment will be conducted in National University Hospital (NUH) for patients diagnosed with IGM.",[26],[99,100,101,27,102,103,104],"Breast","Breast Conditions","Mastits","Inflammation","Breast Surgery","Rhematologist","2025-04-16",{"date":107,"type":46},"2025-04-24",{"date":109,"type":21},"2025-07-01",{"date":111,"type":21},"2028-02-01",{"name":113,"class":83},"National University Hospital, Singapore",1]