Metabolic Phenotypes in Melanoma

NCT05570227 | Recruiting

• 1 other identifier: 21/164
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Melanoma

Keywords

Metabolism

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  5 years

Secondary Outcomes (2)

• Relapse free survival

  5 years

• Overall Survival

  5 years

Other Outcomes (1)

• Tumour Metabolomic and Lipidomic Profiling

  5 years

Study Arms (2)

[U-13C]Glucose Infusion

EXPERIMENTAL

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

No [U-13C]Glucose Infusion

NO INTERVENTION

Blood and tissue samples to be collected for translational research studies, no other additional intervention.

Interventions

[U-13C]Glucose Infusion OTHER

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

[U-13C]Glucose Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (1)

Peter Mac Callum Cancer Centre

Melbourne, Victoria, 3002, Australia

RECRUITING

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Aparna Rao, MBBS PhD

  Peter MacCallum Cancer Centre, Australia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aparna Rao

CONTACT

+61385595000; aparna.rao@petermac.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2022
• First Posted: October 6, 2022
• Study Start: June 27, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 6, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)