Metabolic Phenotypes in Melanoma

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

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

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

  • Diabetes mellitus
  • Pregnancy or breast feeding
  • Patients unable to comply with study procedures and follow up in the opinion of the investigator
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    Eligibility

    Age eligible for study : 18 and older

    Healthy volunteers accepted : No

    Gender eligible for study: All

    Things to know

    Study dates

    Study start: 2023-06-27

    Primary completion: 2027-10-01

    Study completion finish: 2027-10-01

    study type

    Study type

    BASIC_SCIENCE

    phase

    Phase

      NA

    trial

    Trial ID

    NCT05570227

    Intervention or treatment

    OTHER: [U-13C]Glucose Infusion

    Conditions

    • Melanoma

    Find a site

    Closest Location:

    Peter Mac Callum Cancer Centre

    Research sites nearby

    Select from list below to view details:

    • Peter Mac Callum Cancer Centre

      Melbourne, Victoria, Australia

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    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    How is the study designed?

    Participant Group/ArmIntervention/Treatment
    EXPERIMENTAL: [U-13C]Glucose Infusion
    • A 13.3% solution of sterile, pyrogen-free \[U-13C\]glucose in sterile water will be infused intravenously rapidly over 10 minutes to a total dose of 8 grams (bolus dose). Then the infusion will change to a rate of 4 grams/ hour. The infusion will continue until the time of tumour excision or biopsy, planned 2-3 hours.
    OTHER: [U-13C]Glucose Infusion
    • Peri-operative infusion of \[U-13C\]glucose
    NO_INTERVENTION: No [U-13C]Glucose Infusion
    • Blood and tissue samples to be collected for translational research studies, no other additional intervention.
    Not specified

    What is the study measuring?

    Primary outcome

    Primary Outcome MeasurePrimary Outcome DescriptionPrimary Outcome Time Frame
    Glucose Utilisation in the TCA cycleIn 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)5 years
    Lactate Utilisation in the TCA cycleIn 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)5 years

    Secondary outcome

    Secondary Outcome MeasureSecondary Outcome DescriptionSecondary Outcome Time Frame
    Relapse free survivalDefined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first5 years
    Overall SurvivalMeasured as the time of surgery until death from any cause5 years

    Frequently Asked Questions

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    References

    Clinical Trials Gov: Metabolic Phenotypes in Melanoma

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