[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654080":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":50,"studyPopulation":43,"armGroups":51,"interventions":62,"overallOfficials":72,"centralContacts":76,"locations":82,"responsibleParty":110,"collaborators":113,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":121,"acronym":43,"eligibilityCriteria":122,"healthyVolunteers":119,"sex":123,"minAge":43,"maxAge":124,"enrollmentInfo":125,"targetDuration":43,"studyType":128,"phases":129,"briefSummary":131,"conditions":132,"keywords":138,"overallStatus":141,"whyStopped":43,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":151},{"fullName":5,"class":6},"Dana-Farber Cancer Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Antibody-Drug Conjugate (ADC) Target Expression Screening Success Rate [Prospective Cohort]","ADC target expression screening success rate is defined as the proportion of participants who successfully complete bulk RNA sequencing with interpretable results. If immunohistochemistry (IHC) testing is indicated based on the bulk RNA sequencing results, the participant must also successfully complete IHC testing with interpretable results. If IHC testing is not indicated, no further testing is required. Participants who submit a tissue specimen but do not meet these criteria will be classified as screening failures.","Week 6",[14,18,21,24,27,31,34,37,40],{"measure":15,"description":16,"timeFrame":17},"ADC Target Antigen Expression Rate by Bulk RNA Sequencing [Prospective Cohort]","Bulk RNA sequencing is performed on one tumor sample collected from participants with relapsed\u002Frefractory CNS or solid tumors. Expression is defined using a predefined threshold of transcripts per million (TPM) ≥3. The ADC target antigen expression rate is the proportion of participants with expression of at least one evaluated ADC target antigen.","Week 4",{"measure":19,"description":20,"timeFrame":12},"ADC Target Antigen Expression Rate by Immunohistochemistry (IHC) [Prospective Cohort]","IHC is performed on one tumor sample collected from participants with relapsed\u002Frefractory CNS or solid tumors. Candidate ADC target antigens identified by screening bulk RNA sequencing are evaluated by IHC. Protein expression is assessed using semi-quantitative staining intensity scores (0-3+) and H-scores. The ADC target antigen expression rate is the proportion of participants with expression of at least one evaluated ADC target antigen by IHC.",{"measure":22,"description":23,"timeFrame":17},"ADC Target Antigen Transcript Expression Levels by Histologic Diagnosis [Prospective Cohort]","All potential ADC target antigens are evaluated regardless of histologic diagnosis, and transcript expression is quantified using TPM.",{"measure":25,"description":26,"timeFrame":12},"ADC Target Antigen Protein Expression Levels by Histologic Diagnosis [Prospective Cohort]","Candidate ADC target antigens identified by screening bulk RNA sequencing are evaluated by IHC. Protein expression is assessed using semi-quantitative staining intensity scores (0-3+) and H-scores, with higher scores indicating greater protein expression",{"measure":28,"description":29,"timeFrame":30},"Change in ADC Target Antigen Transcript Expression Level from Diagnosis to Relapse [Prospective Cohort]","ADC target antigen transcript expression is measured by bulk RNA sequencing. Transcript expression is quantified as TPM.","48 months",{"measure":32,"description":33,"timeFrame":30},"Change in ADC Target Antigen Protein Expression Level from Diagnosis to Relapse [Prospective Cohort]","ADC target antigen protein expression is measured by IHC. Protein expression is assessed using semi-quantitative staining intensity scores (0-3+) and H-scores, with higher scores indicating greater protein expression.",{"measure":35,"description":36,"timeFrame":30},"ADC Treatment Rate [Prospective Cohort]","ADC treatment rate is defined as the proportion of participants who receive an ADC as part of their clinical care following return of study results.",{"measure":38,"description":39,"timeFrame":30},"ADC Therapy Response Rate [Prospective Cohort]","ADC therapy response rate is defined as the proportion of participants classified as responders according to tumor-specific response criteria. Response is assessed using the International Neuroblastoma Response Criteria (INRC) for neuroblastoma, Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for extracranial solid tumors, and Response Assessment in Neuro-Oncology (RANO) criteria for primary central nervous system (CNS) tumors.",{"measure":41,"description":42,"timeFrame":30},"ADC Therapy Response Rate [Retrospective Cohort]","ADC therapy response rate is defined as the proportion of participants who are classified as responders according to tumor-specific response criteria following ADC therapy.",null,{"allocation":45,"interventionModel":46,"interventionModelDescription":43,"primaryPurpose":47,"observationalModel":43,"timePerspective":43,"maskingInfo":48},"NON_RANDOMIZED","PARALLEL","SCREENING",{"masking":49,"maskingDescription":43,"whoMasked":43},"NONE","This is a non-therapeutic feasibility study evaluating the prospective measurement of antibody-drug conjugate (ADC) target antigen expression in pediatric patients with relapsed or refractory solid or CNS tumors. The study aims to characterize ADC antigen expression patterns, compare expression at diagnosis and relapse, and describe real-world utilization and outcomes of ADCs in pediatric tumors.\n\nParticipants will be enrolled into two cohorts: a prospective cohort and a retrospective cohort.\n\nThe prospective cohort will undergo eligibility screening, enrollment, specimen submission, bulk RNA sequencing screening, followed by immunohistochemistry (IHC) of highly expressed targets, and clinical return of IHC results to their enrolling provider.The retrospective cohort will include participants who have received ADC therapy as part of routine clinical care and will undergo specimen submission, targeted IHC testing, and clinical data collection.\n\nIt is expected that about 130 people will take part in this research.\n\nB+ Foundation is helping to support this research by providing study funding.",[52,58],{"label":53,"type":6,"description":54,"interventionNames":55},"Prospective Cohort","Participants with relapsed\u002Frefractory solid or CNS tumors will undergo eligibility screening, specimen submission, bulk RNA sequencing, and confirmatory IHC testing. IHC results will be returned to the enrolling provider",[56,57],"Diagnostic Test: Bulk RNA Sequencing","Diagnostic Test: Immunohistochemistry (IHC)",{"label":59,"type":6,"description":60,"interventionNames":61},"Retrospective Cohort","Participants who have received ADC therapy as part of routine clinical care will submit specimens for targeted IHC testing and clinical data collection. No RNA sequencing will be performed, and IHC results will not be returned",[57],[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":43},"DIAGNOSTIC_TEST","Bulk RNA Sequencing","Test performed on tumor tissue to measure antibody-drug conjugate (ADC) target expression",[53],{"type":64,"name":69,"description":70,"armGroupLabels":71,"otherNames":43},"Immunohistochemistry (IHC)","Test performed on tumor tissue to confirm protein expression of antibody-drug conjugate (ADC) target antigens identified by bulk RNA sequencing",[53,59],[73],{"name":74,"affiliation":5,"role":75},"Steven Dubois, MD,MS","PRINCIPAL_INVESTIGATOR",[77,81],{"name":74,"role":78,"phone":79,"phoneExt":43,"email":80},"CONTACT","617-632-5460","Steven_Dubois@dfci.harvard.edu",{"name":74,"role":78,"phone":79,"phoneExt":43,"email":43},[83,100],{"facility":84,"status":43,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":90,"geoPoint":95,"contacts":96},"Boston Children's Hospital","Boston","Massachusetts","02115","United States","US",{"type":91,"coordinates":92},"Point",[93,94],-71.05977,42.35843,{"lat":94,"lon":93},[97,99],{"name":98,"role":78,"phone":79,"phoneExt":43,"email":80},"Steven DuBois, MD, MS",{"name":98,"role":75,"phone":43,"phoneExt":43,"email":43},{"facility":101,"status":43,"city":85,"state":86,"zip":87,"country":88,"countryCode":89,"cosmosGeoPoint":102,"geoPoint":104,"contacts":105},"Dana Farber Cancer Institute",{"type":91,"coordinates":103},[93,94],{"lat":94,"lon":93},[106,109],{"name":107,"role":78,"phone":79,"phoneExt":43,"email":108},"Steven G. DuBois, MD, MS","steven_dubois@dfci.harvard.edu",{"name":107,"role":75,"phone":43,"phoneExt":43,"email":43},{"type":75,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Steven DuBois, MD","Principal Investigator",[114],{"name":115,"class":116},"B+ Foundation","UNKNOWN","100654080","pedi-star-surface-target-antibody-drug-conjugate-adc-antigen-expression-in-relapsedrefractory-pediatric-solid-and-cns-tumors-100654080",false,"NCT07793994","Pedi-STAR: Surface Target Antibody-drug Conjugate (ADC) Antigen Expression in Relapsed\u002FRefractory Pediatric Solid and CNS Tumors","Inclusion Criteria:\n\nInclusion Criteria for Prospective Cohort\n\n* Age 0 - 30 years at time of initial diagnosis of the solid or CNS tumor\n* Diagnosis of relapsed or refractory solid or CNS tumor, without a limit on the number of prior episodes of relapse. Refractory disease is defined as disease that progresses on standard-of-care upfront therapy or requires salvage therapy due to inadequate response, e.g. bridging chemoimmunotherapy in a patient with high-risk neuroblastoma and poor end-induction response (PEIR).\n* Life expectancy of at least 12 weeks at the time of enrollment\n* Available specimens Tissue block or unstained slides available expected to yield a minimum of 30 total slides., OR other specimens expected to result in adequate (1) RNA quantity and quality for sequencing and (2) IHC testing may substitute for tissue requirement above with the approval of the PI or study staff designee approval prior to submission enrollment. Tumor tissue from relapse\u002Fprogression is preferred, but tumor tissue from diagnosis if obtained prior to neoadjuvant chemotherapy is acceptable if no relapse\u002Fprogression sample available.Note that this requirement may be reduced to 15 total slides for patients who have already had RNA sequencing performed on their tumor material.\n* Informed consent for participation for adult participants or parental permission for minor participants (with assent as appropriate based on age of participant).\n\nInclusion Criteria for Retrospective Cohort\n\n* Age 0 - 30 years at time of initial diagnosis of the solid or CNS tumor\n* Diagnosis of relapsed or refractory solid or CNS tumor, without a limit on the number of prior episodes of relapse. Refractory disease is defined as disease that progresses on standard-of-care upfront therapy or requires salvage therapy due to inadequate response, e.g. bridging chemoimmunotherapy in a patient with high-risk neuroblastoma and poor end-induction response (PEIR).\n* Available specimens Tissue block or unstained slides available expected to yield a minimum of 15 total slides OR other specimens expected to result in adequate IHC testing may substitute for tissue above with the approval of the PI or study staff approval designee prior to submission.. Tumor tissue from relapse\u002Fprogression is preferred, but tumor tissue from diagnosis if obtained prior to neoadjuvant chemotherapy is acceptable if no relapse\u002Fprogression sample available.\n* Prior receipt of an antibody-drug conjugate (ADC). The ADC may have been received via either commercial supply or as a participant on a clinical trial. The ADC may have been received at any time during a patient's treatment course for relapsed or refractory disease and on or after January 1st, 2011 up to the time of enrollment of the final prospective participant.\n\nExclusion Criteria:\n\nExclusion Criteria for Prospective Cohort\n\n* adults who are unable to consent\n* pregnant women\n* incarcerated individuals","ALL","30 Years",{"count":126,"type":127},130,"ESTIMATED","INTERVENTIONAL",[130],"NA","This study is looking to learn whether a tumor testing approach can feasibly measure antibody-drug conjugate (ADC) target proteins in children and young adults with relapsed or refractory solid tumors or central nervous system (CNS) tumors.\n\nThe tumor testing approach is a two-step tumor profiling process of:\n\n* Screening with bulk RNA sequencing to see which ADC target genes are turned on in the tumor.\n* Confirmatory immunohistochemistry (IHC) for targets that show positive expression on the RNA screen, to confirm protein expression.",[133,134,135,136,137],"CNS Tumor","Solid Tumor","Relapsed Cancer","Refractory Cancer","Pediatric Cancer",[139,140],"Relapsed\u002FRefractory CNS Tumor","Relapsed\u002FRefractory Solid Tumor","NOT_YET_RECRUITING","2026-08-26",{"date":144,"type":145},"2026-08-31","ACTUAL",{"date":147,"type":127},"2026-09",{"date":149,"type":127},"2030-03-31",{"name":5,"class":6},2]