[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572660":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":29,"locations":39,"responsibleParty":92,"collaborators":95,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":18,"enrollmentInfo":109,"targetDuration":18,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":42,"whyStopped":18,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Queen's University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Early Genomic Testing Diagnostic Pathway","EXPERIMENTAL","Participants will receive early genomic testing in addition to standard diagnostic testing.",[13],"Genetic: Genetic testing for inherited bleeding disorders",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard Diagnostic Pathway","NO_INTERVENTION","Participants will receive standard diagnostic testing with the option of receiving genomic testing after 12 months.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"GENETIC","Genetic testing for inherited bleeding disorders","Gene panel for bleeding: This analysis will look at a list of genes known to be associated with rare coagulation, platelet, connective tissue, and bleeding disorders. There are currently 318 genes on the panel however this list may be updated throughout the study. Genes of study include those on the the International Society of Thrombosis and Haemostasis (ISTH) TIER-1 (the first group of genes are the diagnostic-grade) and TIER-2 gene list, as well as additional genes identified in published research.",[9],[26],{"name":27,"affiliation":5,"role":28},"Paula D James, MD, FRCPC","PRINCIPAL_INVESTIGATOR",[30,36],{"name":31,"role":32,"phone":33,"phoneExt":34,"email":35},"Julie Grabell, CCRP","CONTACT","1 613 533 6000","75223","grabell@queensu.ca",{"name":37,"role":32,"phone":33,"phoneExt":34,"email":38},"Megan Chaigneau, RN","megan.chaigneau@queensu.ca",[40,59,75],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Queen's University\u002FKingston Health Sciences Centre","RECRUITING","Kingston","Ontario","K7L 3N6","Canada","CA",{"type":49,"coordinates":50},"Point",[51,52],-76.48098,44.22976,{"lat":52,"lon":51},[55,57,58],{"name":31,"role":32,"phone":56,"phoneExt":34,"email":35},"+16135336000",{"name":37,"role":32,"phone":56,"phoneExt":34,"email":38},{"name":27,"role":28,"phone":18,"phoneExt":18,"email":18},{"facility":60,"status":42,"city":61,"state":44,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"The Ottawa Hospital","Ottawa","K8N 1J4",{"type":49,"coordinates":64},[65,66],-75.69812,45.41117,{"lat":66,"lon":65},[69,73],{"name":70,"role":32,"phone":71,"phoneExt":18,"email":72},"Amanda Pecarskie","+16137378899","apecarskie@ohri.ca",{"name":74,"role":28,"phone":18,"phoneExt":18,"email":18},"Roy Khalifé, MD",{"facility":76,"status":77,"city":78,"state":44,"zip":79,"country":46,"countryCode":47,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Unity Health","NOT_YET_RECRUITING","Toronto","M5B 1W8",{"type":49,"coordinates":81},[82,83],-79.39864,43.70643,{"lat":83,"lon":82},[86,90],{"name":87,"role":32,"phone":88,"phoneExt":18,"email":89},"Clinical Research Manager","+1 416-864-5485","Mercy.charles@unityhealth.to",{"name":91,"role":28,"phone":18,"phoneExt":18,"email":18},"Michelle Sholzberg, MDCM, FRCPC",{"type":28,"investigatorFullName":93,"investigatorTitle":94,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Dr. Paula James","Professor",[96,98],{"name":97,"class":6},"Unity Health Toronto",{"name":60,"class":6},"100572660","early-phase-1-early-genomic-testing-for-inherited-bleeding-disorders-100572660",false,"NCT06736158","Early Genomic Testing for Inherited Bleeding Disorders","Early Genomic Testing for Inherited Bleeding Disorders in Patients Without a Diagnosis After First Line Testing: a Randomized Controlled Trial","GT4BD","Inclusion Criteria:\n\n* New patient referred for abnormal bleeding.\n* Hemostasis expert clinician determined abnormal bleeding history AND family history of bleeding\n* OR no family history of bleeding but hemostasis expert clinician determined severe bleeding history.\n\nExclusion Criteria:\n\n* Prior diagnosis of an inherited bleeding disorder.\n* Acquired cause of bleeding (i.e., medication known to cause bleeding, significant renal or hepatic disease)","ALL","12 Years",{"count":110,"type":111},212,"ESTIMATED","INTERVENTIONAL",[114],"EARLY_PHASE1","The investigators aim to test the introduction of genomic testing early in the diagnostic pathway for inherited bleeding disorders in patients who have not received a diagnosis after first-line testing.\n\nThe goal of this clinical trial is to test the introduction of genomic testing early in the diagnostic pathway for patients referred to Hematology for a suspected inherited bleeding disorder. The main questions it aims to answer are:\n\n1. Does adding early genomic testing increase the number of patients who are diagnosed?\n2. Does adding early genomic testing decrease the overall time to diagnosis?\n3. Is it cost-effective to include early genomic testing in the diagnostic pathway?\n\nThe investigators will compare with a control group of participants who are receiving standard care (no early genomic testing).\n\nParticipants will randomized to a standardized diagnostic testing plus early genomic testing group or to the standardized diagnostic testing group only (with the possibility of being offered genomic testing after 1 year in the study).",[117],"Bleeding Disorder",[119,120],"blood coagulation disorders","bleeding disorder","2025-07-28",{"date":123,"type":124},"2025-07-31","ACTUAL",{"date":126,"type":124},"2025-05-31",{"date":128,"type":111},"2027-04-30",{"name":5,"class":6},3]