[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT03004326":3,"trial-entities:NCT03004326":193,"trial-summary:NCT03004326":203},{"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":28,"study_type":37,"primary_purpose":38,"phases":39,"enrollment_info":40,"interventions":43,"primary_outcomes":44,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":38,"healthy_volunteers":52,"eligibility_criteria":53,"std_ages":76,"locations":80,"central_contacts":177,"overall_officials":181,"references":188,"see_also_links":189},"NCT03004326","VCRC5563","Clinical Transcriptomics in Systemic Vasculitis (CUTIS)","RECRUITING","2028-12","2026-01","2026-01-22","2017-01","Peter Merkel","OTHER",true,"Multi-center observational study to evaluate the histopathology and transcriptome of cutaneous lesions in patients with several different types of vasculitis.","This study employs a multi-center approach to evaluate cutaneous vasculitis across several forms of idiopathic vasculitis. Patients with cutaneous manifestations of vasculitis will be evaluated by teams of primary vasculitis care providers and Dermatologists in order to facilitate optimal selection of patients and sampling of lesions.\n\nA punch skin biopsy at a site of active vasculitis will be the source of material for histopathologic and transcriptomic evaluation. The histopathology of cutaneous vasculitis will be characterized using a standardized approach.",[18,19,20,21,22,23,24,25,26,27],"Cryoglobulinemic Vasculitis (CV)","Drug-induced Vasculitis","Eosinophilic Granulomatosis With Polyangiitis (EGPA)","IgA Vasculitis","Isolated Cutaneous Vasculitis","Granulomatosis With Polyangiitis (GPA)","Microscopic Polyangiitis (MPA)","Polyarteritis Nodosa (PAN)","Urticarial Vasculitis","Vasculitis",[29,30,31,32,33,34,35,36],"DIV","CSS","EGPA","HSP","GPA","MPA","PAN","Wegeners","OBSERVATIONAL",null,[],{"count":41,"type":42},50,"ESTIMATED",[],[45],{"measure":46,"description":47,"timeFrame":48},"Evaluation of clinical data and linked biopsy specimens","Describe cutaneous vasculitis across several different forms of systemic vasculitis using histopathology.","1 year",[],"ALL","5 Years",false,{"inclusion":54,"exclusion":67,"raw_text":75},[55,56,57,58,59,60,61,62,63,64,65,66],"Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis","Have a suspected or confirmed diagnosis of:","Cryoglobulinemic vasculitis (CV)","Drug-induced vasculitis","Eosinophilic granulomatosis with polyangiitis (EGPA)","IgA vasculitis","Isolated cutaneous vasculitis","Granulomatosis with polyangiitis (GPA)","Microscopic polyangiitis (MPA)","Polyarteritis nodosa (PAN)","Urticarial vasculitis","Be willing and able to provide written informed consent (or assent for those under",[68,69,70,71,72,73,74],"You are less than five years old","Considered not to be a candidate for a biopsy or have a higher risk of developing an infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for you participating in this study do not outweigh the potential benefit of learning information from your biopsy","You have a neutrophil count (type of white blood cell) less than 1500\u002Fmm3, platelet count less than 50,000\u002Fmm3, or a hemoglobin less than 7 g\u002FdL","You have an uncontrolled disease that could prevent you from completing the study procedures","You have an active infection at or near the potential biopsy site, have poor circulation, or have bony prominence or other structure that would increase your risk of complications if you participated in this study","You are pregnant or nursing","You are not able to provide informed consent","Inclusion Criteria:\n\n* Have a cutaneous lesion (purpuric macules, palpable purpura, retiform purpura, nodules, ulcers, or urticarial) believed to be related to active vasculitis\n* Have a suspected or confirmed diagnosis of:\n\n  * Cryoglobulinemic vasculitis (CV)\n  * Drug-induced vasculitis\n  * Eosinophilic granulomatosis with polyangiitis (EGPA)\n  * IgA vasculitis\n  * Isolated cutaneous vasculitis\n  * Granulomatosis with polyangiitis (GPA)\n  * Microscopic polyangiitis (MPA)\n  * Polyarteritis nodosa (PAN)\n  * Urticarial vasculitis\n* Be willing and able to provide written informed consent (or assent for those under\n\nExclusion Criteria:\n\n* You are less than five years old\n* Considered not to be a candidate for a biopsy or have a higher risk of developing an infection, bleeding, etc., from the biopsy, or a doctor believes that the risks for you participating in this study do not outweigh the potential benefit of learning information from your biopsy\n* You have a neutrophil count (type of white blood cell) less than 1500\u002Fmm3, platelet count less than 50,000\u002Fmm3, or a hemoglobin less than 7 g\u002FdL\n* You have an uncontrolled disease that could prevent you from completing the study procedures\n* You have an active infection at or near the potential biopsy site, have poor circulation, or have bony prominence or other structure that would increase your risk of complications if you participated in this study\n* You are pregnant or nursing\n* You are not able to provide informed consent",[77,78,79],"CHILD","ADULT","OLDER_ADULT",[81,91,99,107,115,122,135,142,154,166],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"University of California, Los Angeles","COMPLETED","Los Angeles","California","90095","United States",{"lat":89,"lon":90},34.05223,-118.24368,{"facility":92,"status":83,"city":93,"state":94,"zip":95,"country":87,"geoPoint":96},"Boston University School of Medicine","Boston","Massachusetts","02118",{"lat":97,"lon":98},42.35843,-71.05977,{"facility":100,"status":83,"city":101,"state":102,"zip":103,"country":87,"geoPoint":104},"Mayo Clinic","Rochester","Minnesota","55905",{"lat":105,"lon":106},44.02163,-92.4699,{"facility":108,"status":83,"city":109,"state":110,"zip":111,"country":87,"geoPoint":112},"Cleveland Clinic","Cleveland","Ohio","44195",{"lat":113,"lon":114},41.4995,-81.69541,{"facility":116,"status":83,"city":117,"state":118,"country":87,"geoPoint":119},"Oregon Health & Science University","Portland","Oregon",{"lat":120,"lon":121},45.52345,-122.67621,{"facility":123,"status":7,"city":124,"state":125,"zip":126,"country":87,"contacts":127,"geoPoint":132},"University of Pennsylvania","Philadelphia","Pennsylvania","19104",[128],{"name":129,"role":130,"email":131},"Laura Cesar","CONTACT","Laura.Cesar@Pennmedicine.upenn.edu",{"lat":133,"lon":134},39.95238,-75.16362,{"facility":136,"status":83,"city":137,"state":138,"country":87,"geoPoint":139},"University of Utah","Salt Lake City","Utah",{"lat":140,"lon":141},40.76078,-111.89105,{"facility":143,"status":7,"city":144,"state":145,"zip":146,"country":87,"contacts":147,"geoPoint":151},"University of Virginia","Charlottesville","Virginia","22903",[148],{"name":149,"role":130,"email":150},"Lauren Kuhns","lrk9t@uvahealth.org",{"lat":152,"lon":153},38.02931,-78.47668,{"facility":155,"status":7,"city":156,"state":157,"country":158,"contacts":159,"geoPoint":163},"St. Joseph's Healthcare","Hamilton","Ontario","Canada",[160],{"name":161,"role":130,"email":162},"Sandra Messier","smessier@stjoes.ca",{"lat":164,"lon":165},43.25011,-79.84963,{"facility":167,"status":7,"city":168,"state":157,"zip":169,"country":158,"contacts":170,"geoPoint":174},"University of Toronto Mount Sinai Hospital","Toronto","M5G 1X5",[171],{"name":172,"role":130,"email":173},"Nazrana Haq","Nazrana.Haq@sinaihealth.ca",{"lat":175,"lon":176},43.70643,-79.39864,[178],{"name":179,"role":130,"email":180},"Carol McAlear, MA","cmcalear@upenn.edu",[182,185],{"name":183,"affiliation":123,"role":184},"Robert Micheletti, MD","PRINCIPAL_INVESTIGATOR",{"name":186,"affiliation":187,"role":184},"Peter Grayson, MD, MSc","The National Institute of Arthritis and Musculoskeletal and Skin Diseases",[],[190],{"label":191,"url":192},"Related Info","http:\u002F\u002Fwww.rarediseasesnetwork.org\u002Fvcrc",{"nct_id":4,"conditions":194,"biomarkers":202},[195,196,197,198,199,22,200,201,65],"Cryoglobulinemic vasculitis","Drug Induced Cutaneous Vasculitis","Eosinophilic Granulomatosis with Polyangiitis","Granulomatosis with Polyangiitis","Henoch-Schönlein Purpura","Microscopic Polyarteritis","Polyarteritis Nodosa",[],{"nct_id":4,"found":14,"summary":204,"prompt_version":214},{"design":205,"status":206,"heading":207,"summary":208,"follow_up":209,"word_count":210,"commitments":211,"compensation":212,"drugs_mentioned":213},"This is an observational study, meaning researchers will collect information without giving any specific treatments. It plans to include 50 participants.","completed","Observational Study of Vasculitis","This is an observational study called CUTIS, looking at different types of vasculitis (inflammation of blood vessels). Researchers want to understand more about how Cryoglobulinemic Vasculitis, Drug-induced Vasculitis, Eosinophilic Granulomatosis With Polyangiitis (EGPA), IgA Vasculitis, and Isolated Cutaneous Vasculitis affect the skin. They will study skin samples and medical information from people with these conditions. The goal is to learn more about these diseases by looking at clinical data and skin biopsy samples over one year. You may be able to join if you are 5 years or older, have a skin lesion thought to be from active vasculitis, and have a suspected or confirmed diagnosis of one of the listed vasculitis types. The study status is currently unclear.","Your clinical data and biopsy specimens will be evaluated for one year.",119,"You would have a punch skin biopsy taken from an active vasculitis lesion. Your clinical data will also be evaluated.","Not stated in the trial record.",[],"v2"]