Metabolic Phenotypes in Melanoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: [U-13C]Glucose Infusion.
- Who it may be relevant to
- Registry conditions: Melanoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma
Overview
This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.
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.
Interventions
- Other [U-13C]Glucose Infusion
Peri-operative infusion of \[U-13C\]glucose
Primary outcome measures
- Glucose Utilisation in the TCA cycle [Time frame: 5 years]
- Lactate Utilisation in the TCA cycle [Time frame: 5 years]
Secondary outcome measures (2)
- Relapse free survival [Time frame: 5 years]
- Overall Survival [Time frame: 5 years]
Eligibility criteria
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
Patients who meet any of the following criteria will be excluded from receiving a \[U-13C\]Glucose infusion:
- Diabetes mellitus
- Pregnancy or breast feeding
- Patients unable to comply with study procedures and follow up in the opinion of the investigator
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Australia · 1 center
- Peter Mac Callum Cancer Centre — Melbourne
Identifiers
NCT: NCT05570227 · 21/164