Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000678493
Ethics application status
Approved
Date submitted
23/05/2016
Date registered
25/05/2016
Date last updated
31/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Genotypes of skin, hair and eye colour and mole types and distribution in melanoma patients.
Scientific title
Pigmentation genotypes and phenotypic correlations with dermoscopic naevus types and distribution in melanoma patients.
Secondary ID [1] 289267 0
Nil
Universal Trial Number (UTN)
U1111-1183-0942
Trial acronym
n/a
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 298848 0
Condition category
Condition code
Skin 298916 298916 0 0
Dermatological conditions
Cancer 298917 298917 0 0
Malignant melanoma
Human Genetics and Inherited Disorders 298918 298918 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] 294816 0
Not applicable
Comparator / control treatment
uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298383 0
Genotypes that significantly increase or decrease the OR for melanoma risk
Timepoint [1] 298383 0
At recruitment
Secondary outcome [1] 323990 0
Phenotypic and/or genotypic pigmentation characteristics that significantly increase or decrease the OR for melanoma risk
Timepoint [1] 323990 0
At recruitment

Eligibility
Key inclusion criteria
Patients at the Victorian Melanoma Services at Prince Alfred Hospital, with previous/current diagnosis of melanoma.
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
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
25/05/2016
Actual
25/05/2016
Date of last participant enrolment
Anticipated
30/06/2018
Actual
Date of last data collection
Anticipated
30/07/2018
Actual
Sample size
Target
100
Accrual to date
56
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 5829 0
The Alfred - Prahran
Recruitment postcode(s) [1] 13278 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 293648 0
Government body
Name [1] 293648 0
National Health and Medical Research Council (NHMRC)
Country [1] 293648 0
Australia
Primary sponsor type
Individual
Name
Dr Yan Pan
Address
Victorian Melanoma Services
Alfred Hospital
Corner of Commercial Rd and St Kilda Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 292483 0
None
Name [1] 292483 0
none
Address [1] 292483 0
n/a
Country [1] 292483 0
Other collaborator category [1] 279005 0
Individual
Name [1] 279005 0
A/Prof Richard Sturm
Address [1] 279005 0
Dermatology Research Centre
The University of Queensland
Level 5, TRI, 37 Kent Street
Woolloongabba QLD 4102
Country [1] 279005 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295086 0
The Alfred Hospital Ethics Committee
Ethics committee address [1] 295086 0
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [1] 295086 0
Australia
Date submitted for ethics approval [1] 295086 0
25/02/2016
Approval date [1] 295086 0
21/04/2016
Ethics approval number [1] 295086 0
52/16

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 patient of the Victorian Melanoma Service who is able to attend an appointment at the Alfred Hospital and who has had a previous or current melanoma diagnosed. People aged 18 or older 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 underwearas 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.

Data will be combined with a similar, previously registered and ongoing study (trial ID - ACTRN12615000244505).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66058 0
Dr Yan Pan
Address 66058 0
Victorian Melanoma Service
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 66058 0
Australia
Phone 66058 0
+61 3 9076 0365
Fax 66058 0
Email 66058 0
y.pan@alfred.org.au
Contact person for public queries
Name 66059 0
Dr Yan Pan
Address 66059 0
Victorian Melanoma Service
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 66059 0
Australia
Phone 66059 0
+61 3 9076 0365
Fax 66059 0
Email 66059 0
y.pan@alfred.org.au
Contact person for scientific queries
Name 66060 0
Dr Yan Pan
Address 66060 0
Victorian Melanoma Service
The Alfred Hospital
55 Commercial Road
Melbourne VIC 3004
Country 66060 0
Australia
Phone 66060 0
+61 3 9076 0365
Fax 66060 0
Email 66060 0
y.pan@alfred.org.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.