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Trial Title:
Metabolic Phenotypes in Melanoma
NCT ID:
NCT05570227
Condition:
Melanoma
Conditions: Official terms:
Melanoma
Conditions: Keywords:
Metabolism
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Basic Science
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
[U-13C]Glucose Infusion
Description:
Peri-operative infusion of [U-13C]glucose
Arm group label:
[U-13C]Glucose Infusion
Summary:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patient has provided written informed consent
2. Male or female aged 18 years or older at written informed consent
3. Presence of a known melanoma lesion requiring surgical excision or biopsy
4. 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:
1. Diabetes mellitus
2. Pregnancy or breast feeding
3. Patients unable to comply with study procedures and follow up in the opinion of the
investigator
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peter Mac Callum Cancer Centre
Address:
City:
Melbourne
Zip:
3002
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Aparna Rao
Email:
aparna.rao@petermac.org
Start date:
June 27, 2023
Completion date:
October 2027
Lead sponsor:
Agency:
Peter MacCallum Cancer Centre, Australia
Agency class:
Other
Source:
Peter MacCallum Cancer Centre, Australia
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05570227
