[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588598":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":11,"studyPopulation":11,"armGroups":43,"interventions":56,"overallOfficials":73,"centralContacts":78,"locations":83,"responsibleParty":98,"collaborators":11,"id":100,"slug":11,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":11,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":119,"overallStatus":127,"whyStopped":11,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"National University Hospital, Singapore","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":18,"otherOutcomes":11},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients who achieved clinical or radiological complete response by 6 months",null,"6 months",{"measure":14,"description":11,"timeFrame":12},"Time to clinical response and time to radiological response",{"measure":16,"description":11,"timeFrame":17},"Proportion of patients with relapse in a year within affected breast between each arm.","1 year",[19,21,23,25,28,31,34],{"measure":20,"description":11,"timeFrame":17},"Evaluation of side effects.",{"measure":22,"description":11,"timeFrame":12},"Evaluation of of treatment failure (TF) rate",{"measure":24,"description":11,"timeFrame":12},"Evaluation of frequency of percutaneous or surgical intervention required",{"measure":26,"description":11,"timeFrame":27},"Evaluation of potential unique pattern of gene expression that can be used to diagnose IGM and predict treatment response","3 years",{"measure":29,"description":30,"timeFrame":27},"Evaluation of potential biomarkers that may predict response to treatment: eg IL-6, CRP and neutrophil to lymphocyte ratio (NLR)","Depending on the biomarkers tested, there will be different unit of measurements. Some examples of biomarkers that may be tested are:\n\nCRP: mg\u002Fl IL-6: pg\u002Fml NLR: ratio",{"measure":32,"description":33,"timeFrame":27},"Evaluation of patient reported outcome measures","Most of our questions are on a scale from 1 - 5, with some yes or no question and an open question at the end.",{"measure":35,"description":36,"timeFrame":27},"Validate survey instrument for IGM patients","The survey is adopted from SF-36 for general health and EORTC BR23 for body image, breast health and pain.",{"allocation":38,"interventionModel":39,"interventionModelDescription":11,"primaryPurpose":40,"observationalModel":11,"timePerspective":11,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":11,"whoMasked":11},"NONE",[44,50],{"label":45,"type":46,"description":11,"interventionNames":47},"Steroid","ACTIVE_COMPARATOR",[48,49],"Drug: Prednisolone","Drug: Omeprazole 20 mg",{"label":51,"type":52,"description":11,"interventionNames":53},"Methotrexate","EXPERIMENTAL",[54,55],"Drug: Methotrexate","Drug: Folic Acid 5 MG",[57,62,65,69],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"DRUG","Prednisolone","20mg of prednisolone will be prescribed, taken orally, and daily for first month followed by tapering doses of 15mg over one month, then 12.5mg for one month, proceeding to 10mg for one month, subsequently taking 7.5mg for one month, and lastly 5mg for one month.",[45],{"type":58,"name":51,"description":63,"armGroupLabels":64,"otherNames":11},"10mg of methotrexate will be prescribed to be taken once a week for one month. The dosage will be increased to 15mg of methotrexate taken once a week on the 1st (T1) month clinical visit and will be further increased to 20mg of methotrexate taken once a week on the 2nd (T2) month clinical visit. There will be no further escalation of dosage after this visit.",[51],{"type":58,"name":66,"description":67,"armGroupLabels":68,"otherNames":11},"Folic Acid 5 MG","5mg of folic acid is to be taken together with methotrexate once a week.",[51],{"type":58,"name":70,"description":71,"armGroupLabels":72,"otherNames":11},"Omeprazole 20 mg","Omeprazole will be prescribed at 20mg to protect the stomach lining.",[45],[74],{"name":75,"affiliation":76,"role":77},"Serene Si Ning Goh, MBBS","National","PRINCIPAL_INVESTIGATOR",[79],{"name":75,"role":80,"phone":81,"phoneExt":11,"email":82},"CONTACT","+65 9100 6954","serene_sn_goh@nuhs.edu.sg",[84],{"facility":85,"status":11,"city":86,"state":11,"zip":87,"country":86,"countryCode":88,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"National University Hospital","Singapore","119074","SG",{"type":90,"coordinates":91},"Point",[92,93],103.85007,1.28967,{"lat":93,"lon":92},[96],{"name":97,"role":80,"phone":81,"phoneExt":11,"email":82},"Serene Si Ning Goh",{"type":99,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100588598",false,"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","IGM","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","FEMALE","21 Years","60 Years",{"count":111,"type":112},40,"ESTIMATED","INTERVENTIONAL",[115],"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.",[118],"Idiopathic Granulomatous Mastitis",[120,121,122,123,124,125,126],"Breast","Breast Conditions","Mastits","Granulomatous Mastitis","Inflammation","Breast Surgery","Rhematologist","NOT_YET_RECRUITING","2025-04-16",{"date":130,"type":131},"2025-04-24","ACTUAL",{"date":133,"type":112},"2025-07-01",{"date":135,"type":112},"2028-02-01",{"name":5,"class":6},1]