[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609793":3},{"organization":4,"outcomesModule":7,"designInfo":32,"detailedDescription":30,"studyPopulation":30,"armGroups":38,"interventions":45,"overallOfficials":51,"centralContacts":55,"locations":60,"responsibleParty":72,"collaborators":30,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":30,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":30,"enrollmentInfo":83,"targetDuration":30,"studyType":86,"phases":87,"briefSummary":88,"conditions":89,"keywords":30,"overallStatus":91,"whyStopped":30,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"NYU Langone Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Progression-Free Survival (PFS)","PFS is defined as the time from surgery to the time of the first MRI demonstrating radiographic progression (using Response Assessment in Neuro-Oncology \\[RANO\\] criteria) or death due to any cause (whichever occurs earlier).","Up to Year 3 Post-Procedure",[14,17,21,25,28],{"measure":15,"description":16,"timeFrame":12},"Overall Survival (OS)","OS is defined as the time from surgery to the time of death due to any cause (whichever occurs earlier).",{"measure":18,"description":19,"timeFrame":20},"Residual Tumor Volume","Assessed via MRI.","Postoperative Day 1 (POD1)",{"measure":22,"description":23,"timeFrame":24},"Radiographic PFS","Radiographic PFS is defined as the time from surgery to the time of the first MRI demonstrating radiographic progression (using Response Assessment in Neuro-Oncology \\[RANO\\] criteria).","Month 6 Post-Procedure, Month 12 Post-Procedure, Month 24 Post-Procedure, Month 36 Post-Procedure",{"measure":26,"description":27,"timeFrame":12},"Time to Radiographic Recurrence","Time to Radiographic Recurrence is defined as the time from surgery to the time of the first MRI demonstrating radiographic recurrence.",{"measure":29,"description":30,"timeFrame":31},"Percent Change in Mutant Allele Fraction (MAF)",null,"Post-Operative Day 0 (POD0), post-additional resection of tumor-brain interface samples (Up to Year 3)",{"allocation":33,"interventionModel":34,"interventionModelDescription":30,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"NA","SINGLE_GROUP","DIAGNOSTIC",{"masking":37,"maskingDescription":30,"whoMasked":30},"NONE",[39],{"label":40,"type":41,"description":42,"interventionNames":43},"UR-ddPCR During Tumor Biopsy\u002FResection Procedure","EXPERIMENTAL","During the participant's tumor biopsy or resection, the neurosurgeon will perform maximal safe resection, as per standard clinical practice, and allocate nine tissue specimens (three from the core of the tumor and six from the tumor-brain interface) for UR-ddPCR testing. If both core and tumor-brain interface samples test positive and further removal is judged safe, the neurosurgeon may perform additional resection and obtain final specimens from the positive sites before concluding the surgery. Up to 15 tissue specimens may be collected and tested during the procedure. Postoperative care and clinical follow-up will proceed per standard of care.",[44],"Device: UR-ddPCR",[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":30},"DEVICE","UR-ddPCR","The investigational UR-ddPCR assay will be performed on collected tissue specimens during the participant's scheduled surgical visit.",[40],[52],{"name":53,"affiliation":5,"role":54},"Daniel Orringer, MD","PRINCIPAL_INVESTIGATOR",[56],{"name":53,"role":57,"phone":58,"phoneExt":30,"email":59},"CONTACT","(212) 263-0909","Daniel.Orringer@nyulangone.org",[61],{"facility":5,"status":30,"city":62,"state":62,"zip":63,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":30},"New York","10016","United States","US",{"type":67,"coordinates":68},"Point",[69,70],-74.00597,40.71427,{"lat":70,"lon":69},{"type":73,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100609793","residual-idh1-mutant-tumor-cell-quantification-study-100609793",false,"NCT07219199","Residual IDH1-Mutant Tumor Cell Quantification Study","Intraoperative Quantification of Residual IDH1-mutant Tumor Cells Via Ultra-Rapid Droplet Digital PCR","Inclusion Criteria:\n\n* Age ≥ 18 years at the time of consent (any sex)\n* Newly diagnosed diffuse glioma with either (a) radiographic features consistent with IDH-mutant glioma or (b) prior molecular confirmation of an IDH mutation\n* Scheduled for tumor tissue biopsy or surgical resection at NYU Langone Health\n\nExclusion Criteria:\n\n• Active hepatitis C virus (HCV) infection or suspected\u002Fconfirmed prion disease (e.g., Creutzfeldt-Jakob disease), as documented in the medical record or by the treating physician, due to biosafety and tissue- handling restrictions","ALL","18 Years",{"count":84,"type":85},105,"ESTIMATED","INTERVENTIONAL",[33],"This is a single-site, single-arm, prospective, interventional cohort study using intraoperative ultra-rapid droplet digital polymerase chain reaction (UR- ddPCR) to assess residual IDH1-mutant tumor at the end of surgical resection and, if positive, guide additional resection in real-time.",[90],"Glioma","NOT_YET_RECRUITING","2026-09-24",{"date":94,"type":95},"2026-09-29","ACTUAL",{"date":97,"type":85},"2027-08",{"date":99,"type":85},"2032-08",{"name":5,"class":6},1]