[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630700":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":20,"centralContacts":25,"locations":31,"responsibleParty":63,"collaborators":65,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":20,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":20,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":34,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Queensland Centre for Gynaecological Cancer","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Females aged between 50 and 74 years, postmenopausal, and based in Queensland.","OTHER","Blood samples will be collected from 1,500 eligible participants.\n\nParticipants will undergo venous blood collection using a standardised protocol designed to support extracellular vesicle biomarker analysis.\n\nBlood samples and isolated extracellular vesicles will be subjected to predefined storage and transport conditions to evaluate biomarker stability.",[13,14],"Other: Intervention 1","Other: Intervention 2",[16,21],{"type":10,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"Intervention 1","Approximately 30 mL of peripheral venous blood will be collected from each participant using validated blood collection tubes. Samples will be processed according to predefined standard operating procedures, including controlled storage temperatures and defined time-to-processing conditions.",[9],null,{"type":10,"name":22,"description":23,"armGroupLabels":24,"otherNames":20},"Intervention 2","Collected blood samples and derived extracellular vesicles will be exposed to different pre-analytical conditions including:\n\n* Variation in storage temperatures\n* Variation in transport conditions\n* Variation in time from collection to processing\n* Evaluation of extracellular vesicle stability during shipment and storage",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Sara Baniahmadi","CONTACT","+61 7 3346 5073","s.baniahmadi@uq.edu.au",[32,52],{"facility":33,"status":34,"city":35,"state":36,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Mater Misericordiae Ltd","RECRUITING","Brisbane","Queensland","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],153.02809,-27.46794,{"lat":43,"lon":42},[46,49],{"name":47,"role":28,"phone":20,"phoneExt":20,"email":48},"Kaltin Ferguson","kaltin.ferguson@mater.org.au",{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"John Hooper, Professor","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":34,"city":35,"state":36,"zip":20,"country":37,"countryCode":38,"cosmosGeoPoint":54,"geoPoint":56,"contacts":57},"The University of Queensland",{"type":40,"coordinates":55},[42,43],{"lat":43,"lon":42},[58,59,61],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},{"name":60,"role":51,"phone":20,"phoneExt":20,"email":20},"Carlos Salomon, Professor",{"name":62,"role":51,"phone":20,"phoneExt":20,"email":20},"Andreas Obermair, Professor",{"type":64,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[66,67,69,72,74],{"name":53,"class":10},{"name":68,"class":10},"Mater Medical Research Institute",{"name":70,"class":71},"Lions Medical Research Foundation","UNKNOWN",{"name":73,"class":71},"UQ Centre for Extracellular Vesicle Nanomedicine",{"name":75,"class":71},"Australia Ovarian Cancer Research Foundation","100630700","early-study-evaluating-the-specificity-and-feasibility-of-the-early-biomarker-panel-for-ovarian-cancer-detection-100630700",false,"NCT07491081","EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection","Inclusion Criteria:\n\n1. Age between 50 and 74 years (inclusive).\n2. Postmenopausal status, defined as either:\n\n   2.1. At least 12 consecutive months of amenorrhoea following natural menopause or hysterectomy, or 2.2. At least 12 months of hormone replacement therapy (HRT) commenced for the management of menopausal symptoms.\n3. Signed written informed consent.\n\nExclusion Criteria:\n\n1. History of previous ovarian malignancy.\n2. History of bilateral oophorectomy.",true,"FEMALE","50 Years","74 Years",{"count":87,"type":88},1500,"ESTIMATED","INTERVENTIONAL",[91],"NA","The overall aim of the EARLY study is to systematically evaluate the impact of blood collection protocols, storage temperatures, transport conditions, and time to processing on the stability of extracellular vesicle (EV) biomarkers associated with ovarian cancer, with the potential to inform and improve future ovarian cancer screening practices.\n\nThis prospective study will inform future screening studies by:\n\n1. Assessing the feasibility of participant recruitment and blood sample collection for extracellular vesicle analysis in a real-world healthcare setting, including evaluation of the practicality and effectiveness of these processes.\n2. Evaluating the stability of collected and transported blood samples and isolated extracellular vesicles during shipment and storage.\n\nA total of 1,500 participants will be recruited through community groups across Queensland, Australia, in collaboration with the Mater Research Biobank. Eligible participants who provide informed consent will have approximately 30 mL of blood collected for extracellular vesicle analysis. Data will also be collected on demographics (e.g. age and ethnicity), lifestyle factors (e.g. smoking status), medical, surgical and gynaecological history, family history of cancer, date of last menstrual period, and use of hormone replacement therapy (HRT). Participation in the study will conclude after blood sample collection.",[94],"Ovarian Cancer",[96,94,97,98,99],"Ovarian Cancer Detection","Ovarian Cancer Screening","Ovarian Cancer Blood Test","Extracellular Vesicles","2026-03-19",{"date":102,"type":103},"2026-03-24","ACTUAL",{"date":105,"type":103},"2026-02-01",{"date":107,"type":88},"2030-12-31",{"name":5,"class":6},2]