[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100320986":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":24,"locations":34,"responsibleParty":55,"collaborators":57,"id":60,"slug":10,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":10,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":10,"maxAge":67,"enrollmentInfo":68,"targetDuration":10,"studyType":71,"phases":10,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Nicklaus Children's Hospital f\u002Fk\u002Fa Miami Children's Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Genetic Enrollees",null,"Enrollment of patients for whom WGS may be beneficial. Patients who are ill and for whom a genetic diagnosis is suspected but not yet established.",[13],"Genetic: Genetic Enrollees",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":10},"GENETIC","Identification of new genetic diagnoses in children with multiple congenital anomalies, developmental delay, autism, seizures, intellectual disabilities, neurodegenerative disorders and metabolic illness. Samples and data will be stored in a pediatric biorepository. A subset of samples will undergo genetic\u002Fgenomic analysis.",[9],[20],{"name":21,"affiliation":22,"role":23},"Parul Jayakar, MD","Nicklaus Children's Hospital","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":10,"email":29},"Diana Soler, CRC","CONTACT","786-624-2548","diana.soler@nicklaushealth.org",{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},"Jenny Esteves, MBA\u002FMHSA","786-624-2854","jenny.esteves@nicklaushealth.org",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Nickalus Children's Hospital f\u002Fk\u002Fa Miami Children's Hospital","RECRUITING","Miami","Florida","33155","United States",{"type":43,"coordinates":44},"Point",[45,46],-80.19366,25.77427,{"lat":46,"lon":45},[49,50,54],{"name":31,"role":27,"phone":32,"phoneExt":10,"email":33},{"name":51,"role":27,"phone":52,"phoneExt":10,"email":53},"Michelin Janvier, CRC","786-624-3534","michelin.janvier@nicklaushealth.org",{"name":21,"role":23,"phone":10,"phoneExt":10,"email":10},{"type":56,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[58],{"name":59,"class":6},"Rady Pediatric Genomics & Systems Medicine Institute","100320986",false,"NCT03458962","Diagnostic Odyssey: Whole Genome Sequencing (WGS)","Ending the Diagnostic Odyssey: Whole Genome Sequencing (WGS) to Identify Genetic Determinants of Previously Undiagnosed Disease in Children","Inclusion Criteria:\n\n* Symptomatic male or female children ages 0-21 who have un unknown medical condition thought to have an underlying genetic cause after parental consent has been obtained.\n* Willingness of referring provider or other qualified medical staff member to participate in this study by facilitating collection of biologic specimens and clinical information.\n* Patient whose medical condition can be reasonably attributed to a possible genetic etiology.\n* Patient have had at least one diagnostic test without a definite diagnosis.\n\nExclusion Criteria:\n\n* Unwillingness to consent to research.\n* Affected adults (\\>21 years of age), unless they are a biological relative of the affected child.\n* Any patient whose medical condition cannot be reasonably attributed to a possible genetic etiology or there is a prior diagnosis that explains the child's clinical presentation.","ALL","21 Years",{"count":69,"type":70},1000,"ESTIMATED","OBSERVATIONAL","The goal of this collaborative research is to study human genomes in children with suspected congenital disease, multiple-congenital anomalies and\u002For multi-organ disease of unknown etiology by understanding the potential value of Whole Genome Sequencing (WGS) in establishing genetic diagnosis. The study will examine diagnosis rates, changes in clinical care as a result of a genetic diagnosis, health economics including potential cost-effectiveness of WGS and patient and provider experience with genomic medicine.",[74,75],"Genetic Disease","Genetic Syndrome",[77,78,79,80,81,82],"Nicklaus Children's","Pediatric","Genomic","Precision Medicine","Biorepository","Rady Children's","2024-11-06",{"date":85,"type":86},"2024-11-07","ACTUAL",{"date":88,"type":86},"2018-02-20",{"date":90,"type":70},"2070-03",{"name":5,"class":6},1]