[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617051":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":22,"studyPopulation":26,"armGroups":27,"interventions":22,"overallOfficials":31,"centralContacts":35,"locations":40,"responsibleParty":61,"collaborators":63,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":22,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":22,"maxAge":75,"enrollmentInfo":76,"targetDuration":22,"studyType":79,"phases":22,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":43,"whyStopped":22,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"Rate of success of ChromoSeq®","ChromoSeq® will be successful if the results on the first attempt in a real-time, clinical setting identifies recurrent structural variants and copy number alterations of conventional cytogenetics and karyotype. The success rate and the 95% confidence interval will be calculated.","Time of specimen collection to completion of results (total estimated time is 15 days)",[14,18],{"measure":15,"description":16,"timeFrame":17},"Comparison of time-to-results of ChromoSeq® and conventional cytogenetics","The proportion of results return within 15 days and the 95% confidence interval will be calculated.","Time of specimen collection to 15 days after collection (total estimated time is 15 days)",{"measure":19,"description":20,"timeFrame":21},"Frequency of mismatch between LDA standard testing and ChromoSeq® defined Ph-like patients.","The outcome will be measured by determining the correlation of LDA testing on patients with neutral cytogenetics versus LDA testing on patients whose ChromoSeq® results display a Ph-like translocation for validation.","Time of specimen collection to completion of LDA testing (total estimated time is 15 days)",null,{"allocation":22,"interventionModel":22,"interventionModelDescription":22,"primaryPurpose":22,"observationalModel":24,"timePerspective":25,"maskingInfo":22},"CASE_ONLY","PROSPECTIVE","Child and young adult patients with suspected diagnosis or suspected relapse acute lymphoid leukemia (ALL) seen at St. Louis Children's Hospital\u002FWashington University School of Medicine.",[28],{"label":29,"type":22,"description":30,"interventionNames":22},"Child and Young Adult acute lymphoid leukemia (ALL) patients","Data collection will include patient and disease related characteristics such as demographic information, relevant medical history, ALL classification, diagnosis information, treatment, treatment response, recurrence data, and transplant data. Specific clinical data points collected will include ChromoSeq® testing results, minimal residual disease testing results at 8 days into treatment, end of induction (28 days into treatment) and end of consolidation if applicable (\\~3 months into treatment), and time of any relapses from time of diagnosis.",[32],{"name":33,"affiliation":5,"role":34},"Margaret Ferris, MD, PhD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":22,"email":39},"CONTACT","314-454-6018","youngm@wustl.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Washington University School of Medicine\u002FSt. Louis Children's Hospital","RECRUITING","St Louis","Missouri","63110","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-90.19789,38.62727,{"lat":53,"lon":52},[56,57,58],{"name":33,"role":37,"phone":38,"phoneExt":22,"email":39},{"name":33,"role":34,"phone":22,"phoneExt":22,"email":22},{"name":59,"role":60,"phone":22,"phoneExt":22,"email":22},"Feng Gao, PhD","SUB_INVESTIGATOR",{"type":62,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[64],{"name":65,"class":66},"McDonnell Center","UNKNOWN","100617051","whole-genome-sequencing-chromoseq-for-acute-lymphoblastic-leukemia-all-patients-100617051",false,"NCT07313592","Whole Genome Sequencing (ChromoSeq®) for Acute Lymphoblastic Leukemia (ALL) Patients","A Prospective Study of Whole Genome Sequencing (ChromoSeq®) at Diagnosis for Pediatric, Adolescent, and Young Adult Acute Lymphoblastic Leukemia (ALL) Patients","Eligibility Criteria\n\n* Children and young adult patients (\\\u003C 30 years of age at time of study enrollment) treated at St. Louis Children's Hospital\u002FWashington University School of Medicine.\n* Suspected diagnosis or suspected relapse of acute lymphoblastic leukemia (ALL), B- or T-cell.\n* Concurrent enrollment on a prospective therapeutic trial is allowed as this protocol makes no recommendations regarding treatment approach.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. All patients and\u002For their parents or legal guardians must sign an IRB approved written informed consent document.","ALL","30 Years",{"count":77,"type":78},60,"ESTIMATED","OBSERVATIONAL","This is a prospective data collection study evaluating the feasibility of using the ChromoSeq® assay for upfront classification in a real-time clinical setting of pediatric and young patients suspected of having ALL. Sixty patients will undergo collections of bone marrow and\u002For peripheral blood for the ChromoSeq® assay at time of initial workup as part of standard of care, and the patients will then be followed for clinical outcomes for up to 65 months.",[82],"Acute Lymphoblastic Leukemia",[82,84,85,86,87],"B-ALL","T-ALL","Next generation sequencing","Pediatric","2026-10-05",{"date":90,"type":91},"2026-10-09","ACTUAL",{"date":93,"type":91},"2026-06-03",{"date":95,"type":78},"2028-07-15",{"name":5,"class":6},1]