Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621001319864
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
28/09/2021
Date last updated
30/08/2022
Date data sharing statement initially provided
28/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Real world management and outcome of melanoma patients in Australasia using the MASTER registry.
Scientific title
Real world management and outcome of melanoma patients in Australasia using the MASTER registry (MASTER: MelanomA data to capture Standard of care Treatment and outcomEs and to support Research)
Secondary ID [1] 305315 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 322625 0
Condition category
Condition code
Cancer 320246 320246 0 0
Malignant melanoma

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
5
Target follow-up type
Years
Description of intervention(s) / exposure
The follow up period is a minimum of 12 months (and up to 5 years) with extension dependent on funding of registry. Follow up frequency is approximately every 3-6 months. No additional tests are required. The project will capture data from the medical record of patients with histological or cytological confirmed stage III or IV melanoma from January 2020 onwards, from HREC approved sites within Australasia. Information regarding the multi-disciplinary management of melanoma will be collected, including surgery, radiotherapy, systemic therapy and palliative care in the routine clinical practice setting.
Intervention code [1] 321030 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328959 0
Exploring the characteristics of both disease and patients by assessing medical records every 3-6 months.
Timepoint [1] 328959 0
Every 3-6 months for a minimum of 12 months and a maximum of 5 years.
Primary outcome [2] 328960 0
Treatment patterns (regimen/agent, line of therapy) by assessing medical records every 3-6 months .
Timepoint [2] 328960 0
Every 3-6 months for a minimum of 12 months and a maximum of 5 years.
Primary outcome [3] 328961 0
Management of patients (including surgery) by assessing medical records every 3-6 months .
Timepoint [3] 328961 0
Every 3-6 months for a minimum of 12 months and a maximum of 5 years.
Secondary outcome [1] 400949 0
Nil
Timepoint [1] 400949 0
Nil

Eligibility
Key inclusion criteria
1. Patient with stage III or IV cutaneous or unknown primary melanoma
2. Aged 18 years or above at diagnosis
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Both
Statistical methods / analysis
Descriptive statistics will be the primary analysis used to present data from this study,
covering epidemiological measures of interest such as population composition, incidence rates, observed event rates and outcome measures including survival time and hazard ratios/confidence intervals where appropriate for intergroup comparisons.
As this is a descriptive study and no hypothesis will be tested, no formal sample size and power calculations were performed.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/10/2021
Actual
8/04/2022
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
29/12/2023
Actual
Sample size
Target
200
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19866 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 19867 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 19868 0
Yarra Ranges Health - Lilydale
Recruitment hospital [4] 19869 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [5] 19870 0
The Alfred - Melbourne
Recruitment hospital [6] 19871 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [7] 19872 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [8] 19873 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [9] 19874 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [10] 19875 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 34569 0
3128 - Box Hill
Recruitment postcode(s) [2] 34570 0
3135 - Ringwood East
Recruitment postcode(s) [3] 34571 0
3140 - Lilydale
Recruitment postcode(s) [4] 34572 0
3004 - Melbourne
Recruitment postcode(s) [5] 34573 0
3052 - Parkville
Recruitment postcode(s) [6] 34574 0
3084 - Heidelberg
Recruitment postcode(s) [7] 34575 0
3144 - Malvern
Recruitment postcode(s) [8] 34576 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 309036 0
Commercial sector/Industry
Name [1] 309036 0
Merck Sharp & Dohme (Australia) Pty Ltd
Country [1] 309036 0
Australia
Primary sponsor type
Other Collaborative groups
Name
The Walter and Eliza Hall Institute of Medical Research
Address
1G Royal Parade, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 309972 0
Commercial sector/Industry
Name [1] 309972 0
Merck Sharp & Dohme (Australia) Pty Ltd
Address [1] 309972 0
MSD Level 1, 26 Talavera Road
Macquarie Park NSW 2113
Country [1] 309972 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308914 0
Melbourne Health HREC
Ethics committee address [1] 308914 0
Office for Research
Level 2, South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 308914 0
Australia
Date submitted for ethics approval [1] 308914 0
25/11/2020
Approval date [1] 308914 0
02/06/2021
Ethics approval number [1] 308914 0

Summary
Brief summary
The aim of this study (registry) is to document diagnosis, treatment and outcomes for patients with advanced melanoma over time, in order to better understand survival and treatment efficacy in these patients.
Who is it for?
You may be eligible for this study if you are aged 18 years or older, and have been diagnosed with stage III or IV cutaneous or unknown primary melanoma.
Study details
Information regarding the multi-disciplinary management of melanoma, including surgery, radiotherapy, systemic therapy, and palliative care in the routine clinical practice setting is obtained via medical records. Information regarding the clinical outcomes of treatment, including time to disease progression and overall survival, will also be collected. Participants will be followed up for a minimum of 12 months and a maximum of 5 years, if funding for this extension can be secured. No additional tests or time commitment by participants is required.
It is hoped that this study will allow a comprehensive analysis of melanoma diagnosis, treatment and outcomes, supporting much needed basic, translational and clinical research of this disease. This may help to provide insight into optimal management of advanced melanoma in light of new and emerging treatments.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112326 0
Prof Peter Gibbs
Address 112326 0
Gibbs Laboratory
Personalised Oncology Division
The Walter and Eliza Hall Institute of Medical Research (WEHI)
1G Royal Parade
Parkville VIC 3052
Country 112326 0
Australia
Phone 112326 0
+61 3 9345 2897
Fax 112326 0
Email 112326 0
[email protected]
Contact person for public queries
Name 112327 0
Dr Miles Andrews
Address 112327 0
Gibbs Laboratory
Personalised Oncology Division
The Walter and Eliza Hall Institute of Medical Research (WEHI)
1G Royal Parade
Parkville VIC 3052
Country 112327 0
Australia
Phone 112327 0
+61 3 9345 2880
Fax 112327 0
Email 112327 0
[email protected]
Contact person for scientific queries
Name 112328 0
Dr Miles Andrews
Address 112328 0
Gibbs Laboratory
Personalised Oncology Division
The Walter and Eliza Hall Institute of Medical Research (WEHI)
1G Royal Parade
Parkville VIC 3052
Country 112328 0
Australia
Phone 112328 0
+61 3 9345 2880
Fax 112328 0
Email 112328 0
[email protected]

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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.