[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03001180":3,"trial-entities:NCT03001180":98,"trial-summary:NCT03001180":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":25,"study_type":32,"primary_purpose":33,"phases":34,"enrollment_info":35,"interventions":38,"primary_outcomes":39,"secondary_outcomes":47,"sex":48,"minimum_age":49,"maximum_age":33,"healthy_volunteers":14,"eligibility_criteria":50,"std_ages":57,"locations":61,"central_contacts":90,"overall_officials":93,"references":96,"see_also_links":97},"NCT03001180","CCHMC-LMI","Identification of Biomarkers for Patients with Vascular Anomalies","RECRUITING","2050-12","2024-10","2024-11-06","2015-04","Children's Hospital Medical Center, Cincinnati","OTHER",false,"The study will use blood (serum and plasma) and tissue obtained from participants undergoing prescribed surgical resection of vascular anomalies of interest proposed in this study. The study will also use blood (serum and plasma) and tissue collected and stored in a tissue bank maintained by the Department of Hematology\u002FOncology.","While vascular anomalies are rare diseases, they can be life-threatening and devastating to affected children and their families. Advances in diagnosis, monitoring and therapies will be significantly improved if non-invasive biomarkers that are sensitive and specific can be identified. Obtaining a tissue biopsy to help in diagnosis can actually worsen the disease and so identification of specific blood biomarkers is highly desirable. Studies will measure angiogenic factors in serum and plasma samples at baseline and on therapy. Tissue removed during surgical resection or blood removed prior to sclerotherapy will be used to obtain cells and tissue for the assessment of where biomarkers are coming from and to identify disease-causing pathways for new therapeutic targeting.",[18,19,20,21,22,23,24],"Vascular Anomaly","Generalized Lymphatic Anomaly","Kaposiform Hemangioendothelioma","Kaposiform Lymphangiomatosis","Gorham-Stout Disease","Klippel Trenaunay Syndrome","Congenital Lipomatous Overgrowth, Vascular Malformations, and Epidermal Nevi",[19,18,20,21,26,27,28,29,30,31],"Vascular Endothelial Growth Factor","Biomarkers","GLA","KLA","KHE","GSD","OBSERVATIONAL",null,[],{"count":36,"type":37},1000,"ESTIMATED",[],[40,43,45],{"measure":41,"timeFrame":42},"Correlation of Biomarkers with Differential Diagnosis","An Average of Every 2 Years",{"measure":44,"timeFrame":42},"Correlation of Biomarkers with Disease Severity",{"measure":46,"timeFrame":42},"Correlation of Biomarkers with Response to Therapies",[],"ALL","1 Day",{"inclusion":51,"exclusion":54,"raw_text":56},[52,53],"Any patient having labs drawn as standard of care will have blood drawn for the study if consented\u002F assented.","All patients who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank.",[55],"N\u002FA","Inclusion Criteria:\n\n* Any patient having labs drawn as standard of care will have blood drawn for the study if consented\u002F assented.\n* All patients who are undergoing a surgical procedure or sclerotherapy are currently consented for participation in the tissue bank.\n\nExclusion Criteria:\n\n* N\u002FA",[58,59,60],"CHILD","ADULT","OLDER_ADULT",[62,72],{"facility":63,"status":64,"city":65,"state":66,"zip":67,"country":68,"geoPoint":69},"Boston Children's Hospital","TERMINATED","Boston","Massachusetts","02115","United States",{"lat":70,"lon":71},42.35843,-71.05977,{"facility":73,"status":7,"city":74,"state":75,"zip":76,"country":68,"contacts":77,"geoPoint":87},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229",[78,83,85],{"name":79,"role":80,"phone":81,"email":82},"Megan Metcalf","CONTACT","513-803-2606","hvmcresearch@cchmc.org",{"name":84,"role":80},"Timothy LeCras, PhD",{"name":86,"role":80},"Adrienne Hammill, MD, PhD",{"lat":88,"lon":89},39.12711,-84.51439,[91],{"name":84,"role":80,"phone":92,"email":82},"5138034862",[94],{"name":84,"affiliation":12,"role":95},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":99,"biomarkers":106},[100,101,19,102,20,103,104,105],"Congenital Lipomatous Overgrowth","Epidermal Nevus","Gorham's disease","Kaposiform lymphangiomatosis","Klippel Trenaunay syndrome","Vascular malformation",[],{"nct_id":4,"found":108,"summary":109,"prompt_version":119},true,{"design":110,"status":111,"heading":112,"summary":113,"follow_up":114,"word_count":115,"commitments":116,"compensation":117,"drugs_mentioned":118},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to include up to 1000 participants.","completed","Identifying Biomarkers for Vascular Anomalies","This study aims to find specific markers (biomarkers) in blood and tissue that can help doctors better diagnose, monitor, and treat rare conditions called vascular anomalies. These conditions include Generalized Lymphatic Anomaly and Gorham-Stout Disease. Researchers will look at blood samples (serum and plasma) and tissue collected during surgeries or sclerotherapy (a procedure to treat blood vessel problems) to understand what causes these diseases and find new ways to target them with treatments. You may be able to join if you are having blood drawn as part of your regular care or if you are having surgery or sclerotherapy for a vascular anomaly. The study hopes to find biomarkers that correlate with diagnosis, disease severity, and how well treatments work, with measurements taken about every two years. The current recruitment status is unclear.","Researchers will look at how biomarkers correlate with your condition and treatment response about every two years.",133,"If you participate, blood will be drawn during your standard lab work or tissue will be collected during a surgical procedure or sclerotherapy.","Not stated in the trial record.",[],"v2"]