[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545548":3},{"organization":4,"outcomesModule":7,"designInfo":48,"detailedDescription":47,"studyPopulation":47,"armGroups":47,"interventions":54,"overallOfficials":61,"centralContacts":65,"locations":70,"responsibleParty":88,"collaborators":47,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":47,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":111,"overallStatus":73,"whyStopped":47,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Murdoch Childrens Research Institute","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":47},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients who consent to study and complete baseline and at least two longitudinal timepoints with successful measurement of probe drug MR (Metabolic ratio)","This measure is to help inform whether future studies of this nature are feasible and identify if any procedures need to be adjusted to ensure study participant completion.","12 months, 24 Months",[14,17,20,23,26,29,32,35,37,39,42,44],{"measure":15,"description":11,"timeFrame":16},"Percentage of participants completing all required longitudinal blood sampling","Baseline through to 24 Months",{"measure":18,"description":19,"timeFrame":16},"Proportion of participants with successful detection of probe drug overall and at each sampling timepoint","This measure is to help inform whether future studies of this nature are feasible and identify if the method for probe drug detection requires improvement.",{"measure":21,"description":22,"timeFrame":16},"Proportion of participants where phenotype can be classified according to MR overall at each sampling timepoint","This measure is to help inform whether future studies of this nature are feasible and identify if the phenotype can be clearly classified at each timepoint; (i) Prior to commencing first lymphoma chemotherapy cycle (ii) 2 months (week 8) (iii) 4 months (week 16) (iv) Completion of therapy (\\> week 16) (v) Up to a maximum of 2 febrile neutropenic episodes and for how many patients.",{"measure":24,"description":25,"timeFrame":16},"The level of acceptability of participation in pharmacogenomic & phenoconversion testing using the PEGASUS specific survey tool (based on the Theoretical Framework of Acceptability [TFA])","This measure is to help inform whether future studies of this nature are feasible and acceptable. Participants will complete the survey which asks 26 questions, with a numerical scale of 1-7 or a wording scale of 7 choices depending on the question.",{"measure":27,"description":28,"timeFrame":16},"Percentage of participants experiencing an adverse event (AE) during probe drug administration","This measure is to help inform whether future studies of this nature are feasible and identify if\u002Fhow many adverse events are experienced during probe drug administration.",{"measure":30,"description":31,"timeFrame":16},"Incidence of genotype and phenotype mismatch, overall and across longitudinal timepoints","This measure is to help inform whether future studies of this nature are feasible and identify if genotype and phenotype mismatch occurs throughout each timepoint and the overall study.",{"measure":33,"description":34,"timeFrame":16},"Proportion of participants with disease staging and biomarkers of extent of disease","This measure is to help inform whether future studies of this nature are feasible, to identify any variables that stand out and inform future research questions.",{"measure":36,"description":34,"timeFrame":16},"Proportion of participants with a systemic inflammatory state",{"measure":38,"description":34,"timeFrame":16},"Proportion of participants taking medications involving the CYP P450 pathway",{"measure":40,"description":34,"timeFrame":41},"Participant demographic information","Baseline",{"measure":43,"description":34,"timeFrame":16},"Proportion of participants with other environmental factors",{"measure":45,"description":46,"timeFrame":16},"Longitudinal inflammatory profile of participants with Hodgkin or non-Hodgkin Lymphoma as measured by a panel including serum levels of procalcitonin, c-reactive protein and cytokine analysis.","This measure is to identify if there are fluctuations within the inflammatory profile of the patients which helps to inform whether future studies of this nature are feasible. The panel detects a comprehensive set of studied and biologically relevant inflammatory markers including those shown to be predictive of severe infection in children with cancer and febrile neutropenia when out of normal ranges.",null,{"allocation":49,"interventionModel":50,"interventionModelDescription":47,"primaryPurpose":51,"observationalModel":47,"timePerspective":47,"maskingInfo":52},"NON_RANDOMIZED","SINGLE_GROUP","BASIC_SCIENCE",{"masking":53,"maskingDescription":47,"whoMasked":47},"NONE",[55,59],{"type":56,"name":57,"description":58,"armGroupLabels":47,"otherNames":47},"DRUG","Omeprazole","Sub-therapeutic probe drug administration to measure phenoconversion.",{"type":56,"name":60,"description":58,"armGroupLabels":47,"otherNames":47},"Dextromethorphan",[62],{"name":63,"affiliation":5,"role":64},"Rachel Conyers, MBBS (Hons)","PRINCIPAL_INVESTIGATOR",[66],{"name":63,"role":67,"phone":68,"phoneExt":47,"email":69},"CONTACT","+61393455522","rachel.conyers@mcri.edu.au",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"Peter MacCallum Cancer Centre","RECRUITING","Melbourne","Victoria","3000","Australia","AU",{"type":80,"coordinates":81},"Point",[82,83],144.96332,-37.814,{"lat":83,"lon":82},[86],{"name":87,"role":67,"phone":47,"phoneExt":47,"email":47},"Marliese Alexander, Doctor of Philosophy",{"type":89,"investigatorFullName":47,"investigatorTitle":47,"investigatorAffiliation":47,"oldNameTitle":47,"oldOrganization":47},"SPONSOR","100545548","phase-1-a-study-investigating-the-change-in-metabolism-phenotype-in-paediatric-adolescent--young-adults-with-hodgkin-or-non-hodgkin-lymphoma-100545548",false,"NCT06383338","A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma.","A Prospective Feasibility Study Investigating PhEnoconversion of CYP3A4, CYP2C19 and CYP2D6 Genotype in Paediatric and Adolescent and Young Adult patientS With an acUte diagnosiS of Hodgkin or Non-Hodgkin Lymphoma.","PEGASUS","Inclusion Criteria:\n\n* Age 6-25 years of age.\n* New diagnosis of Hodgkin Lymphoma or Non-Hodgkin Lymphoma.\n* Able to swallow and absorb oral or nasogastric tube (NGT) administration of probe drugs.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Failure to comply with inclusion criteria.\n* Has a known previous allergy to any of the probe medications (i.e., omeprazole or dextromethorphan).\n* Common Terminology Criteria for Adverse Events (CTCAE) Grade IV end organ dysfunction (i.e., hepatic, renal, gastrointestinal).\n* Had previous oncological treatment (not first cancer diagnosis).\n* Is a clinically unstable patient requiring intensive care admission in high-risk circumstances will not be considered eligible for consent.\n* Any patient requiring urgent initiation of anti-cancer treatment outside hours where a member of the study staff is unable to approach the parent\u002Fguardian or participant for consent prior to commencing anti-cancer therapy will be ineligible for consent.\n* Unable to provide written informed consent.","ALL","6 Years","25 Years",{"count":102,"type":103},10,"ESTIMATED","INTERVENTIONAL",[106],"PHASE1","PEGASUS aims to test acceptability and feasibility of studying phenoconversion (the change in metabolism phenotype) using probe medications in a paediatric oncology patient population. The study will be conducted in patients (6-25 years of age) with Hodgkin lymphoma or non-Hodgkin lymphoma as exemplar cohort, but with the understanding that cancer-directed and supportive care medicines of the CYP3A4, CYP2C19, and CYP2D6 metabolic pathways are commonly utilised for the treatment of many paediatric, adolescent, young adult, and adult cancers.\n\nThe study involves administration of the probe medication at timepoints which align with pre-determined hospital visits for the treatment of lymphoma and subsequent blood draws to measure the metabolism of the probe medications.\n\nThe acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine.",[109,110],"Hodgkin Lymphoma","Non Hodgkin Lymphoma",[112],"Phenoconversion","2026-08-24",{"date":115,"type":116},"2026-08-27","ACTUAL",{"date":118,"type":116},"2025-07-22",{"date":120,"type":103},"2026-11",{"name":5,"class":6},1]