MetaMel: Metabolic Phenotypes in Melanoma
Study Details
Study Description
Brief Summary
This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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/hour 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: [U-13C]Glucose Infusion 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/ hour. The infusion will continue until the time of tumour excision or biopsy, planned 2-3 hours. |
Other: [U-13C]Glucose Infusion
Peri-operative infusion of [U-13C]glucose
|
| No Intervention: No [U-13C]Glucose Infusion Blood and tissue samples to be collected for translational research studies, no other additional intervention. |
Outcome Measures
Primary Outcome Measures
- Glucose Utilisation in the TCA cycle [5 years]
In patients receiving a [U-13C]Glucose infusion, assess glucose utilisation in the TCA cycle (using the ratio of citrate M+2/pyruvate M+3, a surrogate of the pyruvate dehydrogenase reaction)
- Lactate Utilisation in the TCA cycle [5 years]
In patients receiving a [U-13C]Glucose infusion, assess lactate utilisation in the TCA cycle (using the ratio of lactate M+3/3PG M+3 as a surrogate measure)
Secondary Outcome Measures
- Relapse free survival [5 years]
Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first
- Overall Survival [5 years]
Measured as the time of surgery until death from any cause
Other Outcome Measures
- Tumour Metabolomic and Lipidomic Profiling [5 years]
Abundance of metabolites and lipid species, quantified by liquid chromatography mass spectrometry
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patient has provided written informed consent
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Male or female aged 18 years or older at written informed consent
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Presence of a known melanoma lesion requiring surgical excision or biopsy
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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)
Exclusion Criteria:
Patients who meet any of the following criteria will be excluded from receiving a [U-13C]Glucose infusion:
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Diabetes mellitus
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Pregnancy or breast feeding
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Patients unable to comply with study procedures and follow up in the opinion of the investigator
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Peter MacCallum Cancer Centre, Australia
Investigators
- Principal Investigator: Aparna Rao, MBBS PhD, Peter MacCallum Cancer Centre, Australia
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21/164