[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100490564":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":43,"responsibleParty":111,"collaborators":25,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":115,"sex":121,"minAge":25,"maxAge":122,"enrollmentInfo":123,"targetDuration":25,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":133,"overallStatus":46,"whyStopped":25,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",[8,13],{"label":9,"type":6,"description":10,"interventionNames":11},"Standard of Care","Standard of Care prescribing for period of 12 months. Participants will receive pharmacogenomic test results according to the current standard of care. The participants will be followed up for a minimum of 12 weeks, with maximal time-period being 12 months depending on time of enrolment.",[12],"Diagnostic Test: Release of Extended Pharmacogenomics Report at Week 13",{"label":14,"type":15,"description":16,"interventionNames":17},"Experimental Arm","EXPERIMENTAL","Extended Pharmacogenomic prescribing for a period of 12 months. Participants will receive pharmacogenomic testing across a range of clinically relevant variants, to guide the dose and drug selection of 27 drugs commonly used in supportive care. The participants will be followed up for a minimum of 12 weeks, with maximal time-period being 12 months depending on time of enrolment.",[18,12],"Diagnostic Test: Release of Extended Pharmacogenomics Report at Week 1",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIAGNOSTIC_TEST","Release of Extended Pharmacogenomics Report at Week 1","Whole genome sequencing with reporting on current standard of care (SoC) pharmacogenomic variants (TPMT, NUD15) where applicable (i.e, for patients with diagnosis of acute lymphoblastic leukaemia) by Week 1. Whole genome sequencing on a broader number of actionable variants as per international guidelines for cancer supportive care (identical to study arm) will be reported on at Week 13.",[14],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Release of Extended Pharmacogenomics Report at Week 13","Whole genome sequencing with reporting on current standard of care (SoC) pharmacogenomic variants (TPMT, NUD15) where applicable (i.e, for patients with diagnosis of acute lymphoblastic leukaemia) and reporting of a broader number of actionable pharmacogenomic variants as per international guidelines for cancer supportive care reported on by Week 1.",[14,9],[31],{"name":32,"affiliation":33,"role":34},"A\u002FProf Rachel Conyers","The Royal Children's Hospital\u002FMurdoch Children's Research Institute","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Tayla Stenta","CONTACT","03 9345 5533","pharmaco.genomics@mcri.edu.au",{"name":42,"role":38,"phone":39,"phoneExt":25,"email":40},"Claire Moore",[44,64,80,95],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Sydney Children's Hospital","RECRUITING","Randwick","New South Wales","2031","Australia","AU",{"type":53,"coordinates":54},"Point",[55,56],151.24895,-33.91439,{"lat":56,"lon":55},[59,63],{"name":60,"role":38,"phone":61,"phoneExt":25,"email":62},"Dr. Marion Mateos","+61293821111","m.mateos@unsw.edu.au",{"name":60,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":65,"status":46,"city":66,"state":67,"zip":68,"country":50,"countryCode":51,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"Women's and Children's Hospital","North Adelaide","South Australia","5006",{"type":53,"coordinates":70},[71,72],138.59141,-34.90733,{"lat":72,"lon":71},[75,79],{"name":76,"role":38,"phone":77,"phoneExt":25,"email":78},"Dr Sophie Jessop","+61881617000","sophie.jessop@sa.gov.au",{"name":76,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":81,"status":46,"city":82,"state":83,"zip":84,"country":50,"countryCode":51,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"The Royal Children's Hospital","Parkville","Victoria","3052",{"type":53,"coordinates":86},[87,88],144.95,-37.78333,{"lat":88,"lon":87},[91,94],{"name":32,"role":38,"phone":92,"phoneExt":25,"email":93},"+61393455522","rachel.conyers@rch.org.au",{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"facility":96,"status":46,"city":97,"state":98,"zip":99,"country":50,"countryCode":51,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Perth Children's Hospital","Nedlands","Washington","6009",{"type":53,"coordinates":101},[102,103],115.8073,-31.98184,{"lat":103,"lon":102},[106,110],{"name":107,"role":38,"phone":108,"phoneExt":25,"email":109},"A\u002FProf Rishi Kotecha","+61864562222","rishi.kotecha@health.wa.gov.au",{"name":107,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":112,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100490564","minimising-adverse-drug-reactions-and-verifying-economic-legitimacy-in-children-marvel-pic-100490564",false,"NCT05667766","Minimising Adverse Drug Reactions and Verifying Economic Legitimacy in Children (MARVEL-PIC)","Minimising Adverse Drug Reactions and Verifying Economic Legitimacy - Pharmacogenomics Implementation in Children (MARVEL-PIC)","MARVEL-PIC","Inclusion Criteria:\n\n* Age \\\u003C 18 years\n* New cancer diagnosis or patient receiving HSCT or patient has a relapsed cancer diagnosis and is starting treatment after more than 6 months without.\n* Starting treatment with a chemotherapeutic agent that is not single agent oral targeted therapy.\n* Must also be taking a medication for which there is an established CPIC guideline available.\n* Parent or patient is able and willing to give consent for patient to take part and be followed up for at least 12 weeks.\n* Patient is amenable to venepuncture and blood draw (5mL ideally with an absolute minimum requirement of 2.5 mL) or has Whole Genome Sequencing available (WGS).\n* Patient and\u002For parent is able and willing to sign an informed consent form.\n* Patient and\u002For parent is able to complete Ped-PRO-CTCAE survey in English, Italian or Chinese.\n* Study enrolment limit has not been reached.\n\nExclusion Criteria:\n\n* Age \\> 18 years.\n* Patient has a life expectancy estimated to be less than three months by the treating clinical team.\n* Duration of the drug of inclusion total treatment length is planned to be less than one week.\n* Patient and\u002For parent is unable to consent to the study.\n* Patient and\u002For parent is unwilling to take part in the study.\n* Patient and\u002For parent is able unable to complete Ped-PRO-CTCAE survey in English, Italian or Chinese.\n* Patient has existing impaired hepatic or renal function for which a lower dose or alternate drug selection are already part of current routine care.\n* Patient has a glomerular filtration rate of less than 15 mL\u002Fmin per 1.73m2.\n* Patient has advanced liver failure.","ALL","18 Years",{"count":124,"type":125},880,"ESTIMATED","INTERVENTIONAL",[128],"NA","A prospective, open, randomised implementation study in paediatric cancer patients. The study aims to determine whether a personalised approach will result in an overall reduction in clinically relevant adverse drug reactions (ADRs) and to evaluate the economic and quality of life impacts. Participants will be randomised to receive personalised guided prescribing of supportive care therapy (study arm) or standard of care (control arm) for a period of 12 weeks. The follow up period includes prospective patient reporting of symptoms and quality of life through electronically delivered surveys, for a maximum of 12 months.",[131,132],"Neoplasms","Bone Marrow Transplantation",[134,135,136],"cancer","paediatric","pharmacogenomic","2025-07-15",{"date":139,"type":140},"2025-07-18","ACTUAL",{"date":142,"type":140},"2023-03-22",{"date":144,"type":125},"2027-08",{"name":5,"class":6},4]