Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000244505
Ethics application status
Approved
Date submitted
25/02/2015
Date registered
17/03/2015
Date last updated
10/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Genotypes of skin, hair and eye colour and mole types and distribution in melanoma patients vs non-melanoma patients
Scientific title
Pigmentation genotypes and phenotypic correlations with dermoscopic naevus types and distribution in melanoma patients vs non-melanoma patients
Secondary ID [1] 286271 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 294336 0
Condition category
Condition code
Cancer 294652 294652 0 0
Malignant melanoma
Skin 294653 294653 0 0
Other skin conditions
Human Genetics and Inherited Disorders 294756 294756 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observational study of genotypes and phenotypic correlates of pigmentation and naevus characteristics in melanoma patients, in a one-off appointment for each participant. The participant fills out a questionnaire about sun exposure and medical history, and a research assistant records skin, hair and eye colour, skin reflectance, weight and height, before taking a series of full body images and dermoscopic images of all naevi over 5mm in diameter. This process usually takes between 1 and 2 hours.
Intervention code [1] 291291 0
Not applicable
Comparator / control treatment
Observational study of genotypes and phenotypic correlates of pigmentation and naevus characteristics in volunteers who have not had melanoma.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 294409 0
Genotypes that significantly increase or decrease the OR for melanoma risk
Timepoint [1] 294409 0
At recruitment
Secondary outcome [1] 313226 0
Phenotypic and/or genotypic pigmentation characteristics that significantly increase or decrease the OR for melanoma risk
Timepoint [1] 313226 0
At recruitment
Secondary outcome [2] 313532 0
Phenotypic and/or genotypic naevus characteristics that significantly increase or decrease the OR for melanoma risk
Timepoint [2] 313532 0
At recruitment

Eligibility
Key inclusion criteria
Residents of southeast Queensland and northern NSW who have had a melanoma (cases) or who have not had a melanoma (controls)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/10/2009
Actual
19/10/2009
Date of last participant enrolment
Anticipated
31/12/2016
Actual
11/11/2016
Date of last data collection
Anticipated
Actual
5/12/2016
Sample size
Target
1200
Accrual to date
Final
1251
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 3521 0
Princess Alexandra Hospital - Woolloongabba

Funding & Sponsors
Funding source category [1] 290826 0
Government body
Name [1] 290826 0
National Health and Medical Research Council Grant
Country [1] 290826 0
Australia
Primary sponsor type
Individual
Name
Hans Peter Soyer
Address
Dermatology Research Centre
University of Queensland School of Medicine
Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 289513 0
None
Name [1] 289513 0
Nil
Address [1] 289513 0
Nil
Country [1] 289513 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292445 0
Princess Alexandra Hospital Human Research Ethics Committee
Ethics committee address [1] 292445 0
Ethics committee country [1] 292445 0
Australia
Date submitted for ethics approval [1] 292445 0
Approval date [1] 292445 0
26/08/2009
Ethics approval number [1] 292445 0
HREC/09/QPAH/162
Ethics committee name [2] 292446 0
University of Queensland Medical Research Ethics Committee
Ethics committee address [2] 292446 0
Ethics committee country [2] 292446 0
Australia
Date submitted for ethics approval [2] 292446 0
Approval date [2] 292446 0
14/10/2009
Ethics approval number [2] 292446 0
2009001590

Summary
Brief summary
This study will examine the links between melanoma risk and the genetics controlling skin, hair and eye colour and mole type and distribution.

Who is it for?

You may be eligible to join this study if you are a resident of southeast Queensland or northern NSW who is able to attend an appointment at the Princess Alexandra Hospital and who has had a melanoma (group 1) or who has not had a melanoma (group 2). People of any age are eligible.

Study details

All participants in this study will attend a one-off appointment where they will fill out a questionnaire about their sun exposure and medical history and give a saliva sample for DNA testing. A research assistant will record the participant's skin, hair and eye colour, weight and height and take full body images of the participant in their underwear as well as dermoscopic (close-up) images of moles larger than 5mm in diameter. This usually takes between 1 and 2 hours. We hope that this research will contribute to better melanoma screening procedures and identify people who would benefit from more frequent skin checks.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 55346 0
Prof Hans Peter Soyer
Address 55346 0
Dermatology Research Centre
The University of Queensland, School of Medicine
Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 55346 0
Australia
Phone 55346 0
+61 7 3443 7395
Fax 55346 0
Email 55346 0
p.soyer@uq.edu.au
Contact person for public queries
Name 55347 0
Ms Katie Lee
Address 55347 0
Dermatology Research Centre
The University of Queensland, School of Medicine
Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 55347 0
Australia
Phone 55347 0
+61 7 3443 7482
Fax 55347 0
Email 55347 0
k.lee5@uq.edu.au
Contact person for scientific queries
Name 55348 0
Prof Hans Peter Soyer
Address 55348 0
Dermatology Research Centre
The University of Queensland, School of Medicine
Translational Research Institute
37 Kent St
Woolloongabba QLD 4102
Country 55348 0
Australia
Phone 55348 0
+61 7 3443 7395
Fax 55348 0
Email 55348 0
p.soyer@uq.edu.au

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

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

Documents added automatically
No additional documents have been identified.