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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05570227




Registration number
NCT05570227
Ethics application status
Date submitted
4/10/2022
Date registered
6/10/2022

Titles & IDs
Public title
Metabolic Phenotypes in Melanoma
Scientific title
Identification of Metabolic Phenotypes Associated With Prognosis and Therapeutic Response in Patients With Melanoma
Secondary ID [1] 0 0
21/164
Universal Trial Number (UTN)
Trial acronym
MetaMel
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Malignant melanoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - [U-13C]Glucose Infusion

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.

No intervention: No [U-13C]Glucose Infusion - Blood and tissue samples to be collected for translational research studies, no other additional intervention.


Other interventions: [U-13C]Glucose Infusion
Peri-operative infusion of \[U-13C\]glucose
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Glucose Utilisation in the TCA cycle
Timepoint [1] 0 0
5 years
Primary outcome [2] 0 0
Lactate Utilisation in the TCA cycle
Timepoint [2] 0 0
5 years
Secondary outcome [1] 0 0
Relapse free survival
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
5 years

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2027
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter Mac Callum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3002 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Aparna Rao, MBBS PhD
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Aparna Rao
Address 0 0
Country 0 0
Phone 0 0
+61385595000
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05570227