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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
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Scientific title
Adjuvant Melanoma Stakeholder Treatment Preference Study
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Secondary ID [1]
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CA209-8YR
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Cohort 1 - Participants diagnosed with stage II and stage III melanoma who have undergone surgery
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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Timepoint [1]
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At Baseline
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Self-reported stage IIa
* Self-reported recurrence of melanoma after surgery
Other protocol-defined inclusion/exclusion criteria apply
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
7/01/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
2/06/2022
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Sample size
Target
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Accrual to date
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Final
294
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Local Institution - Melbourne
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Recruitment postcode(s) [1]
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3084 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Bristol-Myers Squibb
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05115006
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
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/NCT05115006
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