Peter Mac Callum Cancer Centre
Melbourne, Victoria, 3002, Australia
Location status: Recruiting
NCT Number: NCT05570227
This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Melbourne, Victoria, 3002, Australia
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients who meet any of the following criteria will be excluded from receiving a [U-13C]Glucose infusion:
Peri-operative infusion of [U-13C]glucose
Time frame: 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)
Time frame: 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)
Time frame: 5 years
Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first
Time frame: 5 years
Measured as the time of surgery until death from any cause
Time frame: 5 years
Abundance of metabolites and lipid species, quantified by liquid chromatography mass spectrometry
Contact information is provided by the study sponsor or research team.
Peter MacCallum Cancer Centre, Australia
Other
Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma
Acronym: MetaMel
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05355701
Advanced Colorectal Cancer (Part 1), Bronchial Neoplasms
Aurora, Colorado, United States
View Trial DetailsNCT07628634
Adenocarcinoma, Basal Cell Carcinoma
Orange, California, United States
View Trial DetailsNCT07285044
Adenocarcinoma, Adnexal Diseases
Jacksonville, Florida, United States
View Trial DetailsNCT05373823
Behavior, Health Behavior
New Brunswick, New Jersey, United States
View Trial Details