Metabolic Phenotypes in Melanoma
This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Patient has provided written informed consent
- Male or female aged 18 years or older at written informed consent
- Presence of a known melanoma lesion requiring surgical excision or biopsy
- 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
- Diabetes mellitus
- Pregnancy or breast feeding
- Patients unable to comply with study procedures and follow up in the opinion of the investigator
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
BASIC_SCIENCE
Phase
- NA
Study ID
NCT05570227
Intervention or treatment
OTHER: [U-13C]Glucose Infusion
Conditions
- Melanoma
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Research sites nearby
Closest Location:
Peter Mac Callum Cancer Centre
Select from list below to view details:
Peter Mac Callum Cancer Centre
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Peter MacCallum Cancer Centre, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: [U-13C]Glucose Infusion
| Other: [U-13C]Glucose Infusion |
NO_INTERVENTION: No [U-13C]Glucose Infusion
|
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| 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/pyruvate M+3, a surrogate of the pyruvate dehydrogenase reaction) | 5 years |
| 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+3/3PG M+3 as a surrogate measure) | 5 years |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Relapse free survival | Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first | 5 years |
| Overall Survival | Measured as the time of surgery until death from any cause | 5 years |
References
Clinical Trials Gov: Metabolic Phenotypes in MelanomaOther trials to consider
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