[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652040":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":10,"responsibleParty":22,"collaborators":10,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":29,"acronym":10,"eligibilityCriteria":30,"healthyVolunteers":26,"sex":31,"minAge":32,"maxAge":33,"enrollmentInfo":34,"targetDuration":10,"studyType":37,"phases":10,"briefSummary":38,"conditions":39,"keywords":41,"overallStatus":48,"whyStopped":10,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":10},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Complex Vascular Anomaly Group",null,"Patients with vascular anomalies that were treated with mTOR inhibitors (sirolimus\u002Feverolimus), a MEK inhibitor (trametinib), and a PIK3CA inhibitor (alpelisib) for a minimum of 3 months.",[13],{"name":14,"affiliation":14,"role":15},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[17,21],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":14,"role":18,"phone":10,"phoneExt":10,"email":10},{"type":23,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100652040","a-study-of-clinical-practice-and-real-world-care-of-patients-treated-with-mtor-pi3k-and-mek-inhibitors-for-extracranial-vascular-anomalies-100652040",false,"NCT07767877","A Study of Clinical Practice and Real-world Care of Patients Treated With mTOR, PI3K, and MEK Inhibitors for Extracranial Vascular Anomalies","Targeted Therapies for Vascular Anomalies: A MultiCenter Real World Registry A Review of Clinical Practice and Real-world Care of Patients Treated With mTOR, PI3K, and MEK Inhibitors for Extracranial Vascular Anomalies","Inclusion criteria:\n\n* Diagnosed with a spectrum of vascular anomalies including but not limited to congenital vascular and lymphatic anomalies, vascular tumors and lymphatic malformations, and acquired vascular malformations.\n* Treated with ≥1 of mammalian target of rapamycin (mTOR) inhibitors, mitogen-activated protein kinase\u002FERK kinase (MEK) inhibitors and phosphoinositide 3-kinase (PI3K) inhibitors continuously for 3 months.\n\nExclusion criteria:\n\n* Patients diagnosed with a vascular anomaly who have not been treated with mTOR inhibitors, MEK inhibitors and PI3K inhibitors for at least 3 months.\n* Patients with other complex medical conditions; i.e. rare genetic syndromes.\n* Patients receiving many other systemic therapies making data collection not feasible.\n* Recurrent use of immunosuppressive agents, i.e. systemic steroids or targeted medical therapies for oncologic disorders, etc.\n* Patients with significant gaps in data collection.\n* Patients with concurrent enrollment in interventional trials.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","ALL","0 Years","90 Years",{"count":35,"type":36},200,"ESTIMATED","OBSERVATIONAL","This study aims to describe real-world patient characteristics, treatment patterns, and adverse events associated with targeted therapies used in patients with complex vascular anomalies. The study will create an active registry for participating centers to enter data on patients with complex vascular anomalies being treated with sirolimus\u002Feverolimus (mTOR inhibitors), with\u002Fwithout trametinib (MEK inhibitor), or alpelisib (PIK3CA inhibitor). Tertiary care centers in the United States (US) that receive referrals for complex vascular anomaly cases and use Electronic Health Records (EHRs) will contribute patient medical chart reviews to this registry.",[40],"Vascular Anomalies",[42,43,44,45,46,47],"Vascular anomaly","Targeted therapy","Pi3KCA inhibitor","mTOR inhibitor","MEK inhibitor","QoL","NOT_YET_RECRUITING","2026-08-11",{"date":51,"type":52},"2026-08-17","ACTUAL",{"date":54,"type":36},"2026-08-31",{"date":56,"type":36},"2027-10-30",{"name":14,"class":6}]