Metabolic Phenotypes in Melanoma

Melanoma Clinical Trial

— MetaMel  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570227
• Other study ID #: 21/164
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: October 2027

Study information

• Verified date: July 2023
• Source: Peter MacCallum Cancer Centre, Australia
• Contact: Aparna Rao
• Phone: +61385595000
• Email: aparna.rao[@]petermac.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: October 2027
• Est. primary completion date: October 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patient has provided written informed consent

2. Male or female aged 18 years or older at written informed consent

3. Presence of a known melanoma lesion requiring surgical excision or biopsy

4. 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:

1. Diabetes mellitus

2. Pregnancy or breast feeding

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• [U-13C]Glucose Infusion
Peri-operative infusion of [U-13C]glucose

Locations

Country	Name	City	State
Australia	Peter Mac Callum Cancer Centre	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tumour Metabolomic and Lipidomic Profiling	Abundance of metabolites and lipid species, quantified by liquid chromatography mass spectrometry	5 years
Primary	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
Primary	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	Relapse free survival	Defined as the time from surgery to disease recurrence or melanoma-related death, whichever occurs first	5 years
Secondary	Overall Survival	Measured as the time of surgery until death from any cause	5 years