Metabolic Phenotypes in Melanoma

ConditionMelanoma

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorPeter MacCallum Cancer Centre, Australia

About this trial

This is a single centre, correlative, longitudinal, biomarker study that aims to describe the metabolic features of human melanoma using mass spectrometry.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Diabetes mellitus

Pregnancy or breast feeding

Patients unable to comply with study procedures and follow up in the opinion of the investigator

Trial design

Design model

Parallel

Treatments tested in this trial

[U-13C]Glucose Infusion
Other intervention
Peri-operative infusion of \[U-13C\]glucose

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: [U-13C]Glucose InfusionExperimental treatment 1 intervention

Group B: No [U-13C]Glucose InfusionNo intervention 0 interventions

Trial outcomes

Primary outcomes

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)

Time frame

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)

Time frame

5 years

Secondary outcomes

Relapse free survival

Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first

Time frame

5 years

Overall Survival

Measured as the time of surgery until death from any cause

Time frame

5 years

Other outcomes

Tumour Metabolomic and Lipidomic Profiling

Abundance of metabolites and lipid species, quantified by liquid chromatography mass spectrometry

Time frame

5 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peter MacCallum Cancer Centre, Australia

Lead sponsor

Source ClinicalTrials.gov

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