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Island","02886",{"type":48,"coordinates":212},[213,214],-71.41617,41.7001,{"lat":214,"lon":213},{"facility":217,"status":41,"city":218,"state":219,"zip":220,"country":45,"countryCode":46,"cosmosGeoPoint":221,"geoPoint":225,"contacts":10},"AIR Care","Dallas","Texas","75231",{"type":48,"coordinates":222},[223,224],-96.80667,32.78306,{"lat":224,"lon":223},{"type":227,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100603988","screening-study-for-kit-d816v-mutated-mast-cell-disease-in-select-populations-100603988",false,"NCT07143669","Screening Study for KIT D816V Mutated Mast Cell Disease in Select Populations","A Multicenter Screening Study to Characterize the Prevalence of the KIT D816V Mutation in Patients With Suspected Clonal Mast Cell Disease","Key Inclusion Criteria:\n\n* Cohort 1 participants must meet inclusion criteria for either SMAC-A or SMAC-B:\n\n  1\\. SMAC-A\n* Documented anaphylaxis due to Hymenoptera venom with cardiovascular symptoms or\n* Documented anaphylaxis without known trigger(s) or allergen(s) warranting hospitalization, emergency room visit, and\u002For epinephrine with cardiovascular symptoms 2. SMAC-B\n* Episodic or recurrent signs and symptoms consistent with mast cell activation without known triggers or allergens in at least 2 of the following organ systems: skin, respiratory\u002Fnaso-ocular, gastrointestinal tract, or cardiovascular.\n* Any clinical response on one or more optimally dosed therapies intended to mitigate mast cell mediators, as determined by the Investigator.\n* Cohort 2 participants must have confirmed, known diagnosis of 1 of the following criteria:\n\n  1. Either hypermobile Ehlers-Danlos syndrome or documented history of hypermobility spectrum disorder.\n  2. Postural orthostatic tachycardia syndrome with one or more systemic symptoms.\n  3. Early onset (≤50 years old) osteoporosis or osteopenia.\n* Cohort 3 participants must have documented diagnosis of 1 of the following, according to World Health Organization 5th edition criteria: chronic myelomonocytic leukemia or myelodysplastic syndrome\u002Fmyeloproliferative neoplasm not otherwise specified.\n\nKey Exclusion Criteria:\n\n* Participants previously diagnosed with any of the following:\n\n  1. Monoclonal mast cell activation syndrome with a known KIT mutation\n  2. Cutaneous mastocytosis only (that is, no documentation of systemic mast cell disease via bone marrow biopsy)\n  3. Any subtype of systemic mastocytosis\n  4. Mast cell sarcoma\n* Cohort 2 only: Osteopenia or osteoporosis attributed to known genetic, endocrine, nutritional, or other medical conditions.\n\nNote: Additional protocol-defined criteria apply.","ALL","18 Years",{"count":238,"type":239},450,"ESTIMATED","OBSERVATIONAL","This is a multicenter screening study to characterize the prevalence of the KIT D816V mutation in participants with suspected clonal mast cell disease.",[243,244,245],"Clonal Mast Cell Disease","KIT D816V Mutation","Suspected KITD816V Mutated Clonal Mast Cell Disease",[247,248,249,250,251,252],"Mast Cell Activation Disorder","MDS\u002FMPN Overlap Syndrome","Chronic Myelomonocytic Leukemia","Hypermobility Syndrome Disorder","Postural Orthostatic Tachycardia Syndrome","Early Onset Osteoporosis","2026-06-23",{"date":255,"type":256},"2026-06-25","ACTUAL",{"date":258,"type":256},"2025-10-17",{"date":260,"type":239},"2028-10-31",{"name":5,"class":6},19]