Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05115006




Registration number
NCT05115006
Ethics application status
Date submitted
28/10/2021
Date registered
10/11/2021
Date last updated
30/06/2022

Titles & IDs
Public title
A Study of Adjuvant Melanoma Stakeholder Treatment Preferences
Scientific title
Adjuvant Melanoma Stakeholder Treatment Preference Study
Secondary ID [1] 0 0
CA209-8YR
Universal Trial Number (UTN)
Trial acronym
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort 1 - Participants diagnosed with stage II and stage III melanoma who have undergone surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Preference weights or utilities (a measure of relative preference; on a continuous variable scale) for each treatment attribute level based on responses to the Discrete Choice Experiment (DCE) choice tasks
Timepoint [1] 0 0
At Baseline

Eligibility
Key inclusion criteria
* Self-reported medical diagnosis of stage II or stage III melanoma
* Have been resected (had surgery) for their melanoma within 12 months prior to study participation
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Self-reported stage IIa
* Self-reported recurrence of melanoma after surgery

Other protocol-defined inclusion/exclusion criteria apply

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
7/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/06/2022
Sample size
Target
Accrual to date
Final
294
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Local Institution - Melbourne
Recruitment postcode(s) [1] 0 0
3084 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to understand the trade-offs that participants with surgically treated melanoma would be willing to make among key features and outcomes of adjuvant anti-cancer treatments or no adjuvant treatment / observation.
Trial website
https://clinicaltrials.gov/study/NCT05115006
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05115006