protocolSection identificationModule nctId: NCT06383338, orgStudyIdInfo id: PEGASUS, briefTitle: A Study Investigating the Change in Metabolism Phenotype in Paediatric, Adolescent & Young Adults With Hodgkin or Non-Hodgkin Lymphoma., acronym: PEGASUS, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2025-05, completionDateStruct date: 2026-05, studyFirstPostDateStruct date: 2024-04-25, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Murdoch Childrens Research Institute, class: OTHER, descriptionModule briefSummary: 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.The 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.The acceptability and feasibility of this study will inform future studies in phenoconversion within the paediatric cancer population to direct more personalised precision medicine., conditionsModule conditions: Hodgkin Lymphoma, conditions: Non Hodgkin Lymphoma, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Omeprazole, interventions name: Dextromethorphan, outcomesModule primaryOutcomes measure: 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), secondaryOutcomes measure: Percentage of participants completing all required longitudinal blood sampling, secondaryOutcomes measure: Proportion of participants with successful detection of probe drug overall and at each sampling timepoint, secondaryOutcomes measure: Proportion of participants where phenotype can be classified according to MR overall at each sampling timepoint, secondaryOutcomes measure: The level of acceptability of participation in pharmacogenomic & phenoconversion testing using the PEGASUS specific survey tool (based on the Theoretical Framework of Acceptability [TFA]), secondaryOutcomes measure: Percentage of participants experiencing an adverse event (AE) during probe drug administration, secondaryOutcomes measure: Incidence of genotype and phenotype mismatch, overall and across longitudinal timepoints, secondaryOutcomes measure: Proportion of participants with disease staging and biomarkers of extent of disease, secondaryOutcomes measure: Proportion of participants with a systemic inflammatory state, secondaryOutcomes measure: Proportion of participants taking medications involving the CYP P450 pathway, secondaryOutcomes measure: Participant demographic information, secondaryOutcomes measure: Proportion of participants with other environmental factors, secondaryOutcomes measure: 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., eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 25 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Peter MacCallum Cancer Centre, city: Melbourne, state: Victoria, zip: 3000, country: Australia, contacts name: Marliese Alexander, Doctor of Philosophy, role: CONTACT, geoPoint lat: -37.814, lon: 144.96332, hasResults: False