[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483068":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":34,"studyPopulation":30,"armGroups":35,"interventions":46,"overallOfficials":50,"centralContacts":54,"locations":60,"responsibleParty":77,"collaborators":30,"id":79,"slug":30,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":30,"enrollmentInfo":88,"targetDuration":30,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":63,"whyStopped":30,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Peter MacCallum Cancer Centre, Australia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":23},[9,13],{"measure":10,"description":11,"timeFrame":12},"Glucose Utilisation in the TCA cycle","In patients receiving a \\[U-13C\\]Glucose infusion, assess glucose utilisation in the TCA cycle (using the ratio of citrate M+2\u002Fpyruvate M+3, a surrogate of the pyruvate dehydrogenase reaction)","5 years",{"measure":14,"description":15,"timeFrame":12},"Lactate Utilisation in the TCA cycle","In patients receiving a \\[U-13C\\]Glucose infusion, assess lactate utilisation in the TCA cycle (using the ratio of lactate M+3\u002F3PG M+3 as a surrogate measure)",[17,20],{"measure":18,"description":19,"timeFrame":12},"Relapse free survival","Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first",{"measure":21,"description":22,"timeFrame":12},"Overall Survival","Measured as the time of surgery until death from any cause",[24],{"measure":25,"description":26,"timeFrame":12},"Tumour Metabolomic and Lipidomic Profiling","Abundance of metabolites and lipid species, quantified by liquid chromatography mass spectrometry",{"allocation":28,"interventionModel":29,"interventionModelDescription":30,"primaryPurpose":31,"observationalModel":30,"timePerspective":30,"maskingInfo":32},"NON_RANDOMIZED","PARALLEL",null,"BASIC_SCIENCE",{"masking":33,"maskingDescription":30,"whoMasked":30},"NONE","This is a single-centre, correlative study designed to investigate metabolic phenotypes in a longitudinal cohort of patients with melanoma. This study will involve the collection of tissue at the time of surgical excision or biopsy. The key intervention, in a subset of patients, will be to perform peri-operative infusions of a stable isotope, \\[U13C\\]Glucose. Patients will be intravenously administered sterile, pyrogen-free 13C-glucose, delivered as an 8g bolus followed by infusion of 4g\u002Fhour for 2-3 hours. Blood samples will be obtained to monitor glucose and to analyse enrichment of labelled nutrients by gas-chromatography mass spectrometry (GC-MS). At the time of resection or biopsy, tumour samples will be divided and either immediately frozen in liquid nitrogen or processed to form patient-derived xenografts. Frozen tumour samples will be subsequently processed for: isotope enrichment by GC-MS; global metabolomics by liquid-chromatography mass spectrometry (LC-MS); and genomic analyses. Relevant clinical, histologic and genomic features will also be correlated with metabolic findings.",[36,42],{"label":37,"type":38,"description":39,"interventionNames":40},"[U-13C]Glucose Infusion","EXPERIMENTAL","A 13.3% solution of sterile, pyrogen-free \\[U-13C\\]glucose in sterile water will be infused intravenously rapidly over 10 minutes to a total dose of 8 grams (bolus dose). Then the infusion will change to a rate of 4 grams\u002F hour. The infusion will continue until the time of tumour excision or biopsy, planned 2-3 hours.",[41],"Other: [U-13C]Glucose Infusion",{"label":43,"type":44,"description":45,"interventionNames":30},"No [U-13C]Glucose Infusion","NO_INTERVENTION","Blood and tissue samples to be collected for translational research studies, no other additional intervention.",[47],{"type":6,"name":37,"description":48,"armGroupLabels":49,"otherNames":30},"Peri-operative infusion of \\[U-13C\\]glucose",[37],[51],{"name":52,"affiliation":5,"role":53},"Aparna Rao, MBBS PhD","PRINCIPAL_INVESTIGATOR",[55],{"name":56,"role":57,"phone":58,"phoneExt":30,"email":59},"Aparna Rao","CONTACT","+61385595000","aparna.rao@petermac.org",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Peter Mac Callum Cancer Centre","RECRUITING","Melbourne","Victoria","3002","Australia","AU",{"type":70,"coordinates":71},"Point",[72,73],144.96332,-37.814,{"lat":73,"lon":72},[76],{"name":56,"role":57,"phone":30,"phoneExt":30,"email":59},{"type":78,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100483068",false,"NCT05570227","Metabolic Phenotypes in Melanoma","Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma","MetaMel","Inclusion Criteria:\n\n1. Patient has provided written informed consent\n2. Male or female aged 18 years or older at written informed consent\n3. Presence of a known melanoma lesion requiring surgical excision or biopsy\n4. Patient is willing and able to comply with the protocol for the duration of the study including undergoing biopsies and receiving a stable isotope infusion (where applicable)\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from receiving a \\[U-13C\\]Glucose infusion:\n\n1. Diabetes mellitus\n2. Pregnancy or breast feeding\n3. Patients unable to comply with study procedures and follow up in the opinion of the investigator","ALL","18 Years",{"count":89,"type":90},240,"ESTIMATED","INTERVENTIONAL",[93],"NA","This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.",[96],"Melanoma",[98],"Metabolism","2023-07-03",{"date":101,"type":102},"2023-07-06","ACTUAL",{"date":104,"type":102},"2023-06-27",{"date":106,"type":90},"2027-10",{"name":5,"class":6},1]