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Recruiting Not applicable NCT05570227

Metabolic Phenotypes in Melanoma

No applicable phase (e.g. observational)
Conditions: Melanoma

Sponsor: Peter MacCallum Cancer Centre, Australia

trial.available_in: БГ
Overview
This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.
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.
Who can participate
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
Locations 1
Australia (1)
Peter Mac Callum Cancer Centre
Melbourne , Victoria
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
27.06.2023
Completion date
01.10.2027
Registry ID
NCT05570227
Source
anzctr
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