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NCT Number: NCT05570227

Metabolic Phenotypes in Melanoma

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peter Mac Callum Cancer Centre

Melbourne, Victoria, 3002, Australia

Location status: Recruiting

Location contact

Aparna Rao

CONTACT

[email protected]

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[U-13C]Glucose Infusion

Other

Peri-operative infusion of [U-13C]glucose

Primary outcomes

  1. Glucose Utilisation in the TCA cycle

    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)

  2. Lactate Utilisation in the TCA cycle

    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)

Secondary outcomes

  1. Relapse free survival

    Time frame: 5 years

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

  2. Overall Survival

    Time frame: 5 years

    Measured as the time of surgery until death from any cause

Other outcomes

  1. Tumour Metabolomic and Lipidomic Profiling

    Time frame: 5 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Aparna Rao

CONTACT

[email protected]

+61385595000

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Registry information

Official study title

Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma

Acronym: MetaMel

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 6, 2022
Registry last updated
Jul 6, 2023

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.

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