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Trial registered on ANZCTR


Registration number
ACTRN12619001706167
Ethics application status
Approved
Date submitted
26/11/2019
Date registered
4/12/2019
Date last updated
28/06/2021
Date data sharing statement initially provided
4/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Australian Centre of Excellence in Melanoma Imaging & Diagnosis Cohort Study
Scientific title
Three-dimensional total body photography for the early detection of melanoma and other skin cancers in people with low to very high risk of melanoma
Secondary ID [1] 299339 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACEMID
Linked study record


Health condition
Health condition(s) or problem(s) studied:
Melanoma 314430 0
Keratinocyte skin cancer 314487 0
Naevi 315333 0
Condition category
Condition code
Cancer 312775 312775 0 0
Malignant melanoma
Cancer 312824 312824 0 0
Non melanoma skin cancer
Skin 313635 313635 0 0
Dermatological conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will undergo three-dimensional total body (excluding skin beneath underwear and scalp) photography using the VECTRA whole-body scanner (VECTRA WB360 Serial Number WB00009, Canfield Scientific Inc, Parsippany, NJ, USA). The VECTRA whole-body scanner consists of 92 cameras with white or cross-polarised lighting, which simultaneously captures images to construct a digital 3D avatar of the participant, providing a record of all pigmented and non-pigmented skin lesions including naevi. A melanographer and dermatologically-trained medical practitioner will conduct the study visits and conduct the 3D total body photography.

Participants will also complete questionnaires to obtain information on their demographics, sun behaviour, quality of life, skin cancer history and medical history. Study clinic visits will take approximately 30 minutes to an hour. The frequency of follow-up clinic visits will be based on the participant’s melanoma risk for the study duration of 3 years. The participant's risk will be assessed using a validated melanoma risk assessment tool developed by the NSW team. Participants' melanoma risk will be assessed at each visit; thus, if their melanoma risk changes, the participant will be reassigned into the corresponding melanoma risk level group.

1. Low/Average Risk Group
Participants with a low or average risk of melanoma will be seen at the clinic for repeat 3D total body photography and dermoscopy every 24 months. In some cases, participants may be asked to return in 12 months’ time to monitor any changes suspicious skin lesions, on the discretion of the dermatologist.

2. High Risk Group
Participants identified as having high risk of melanoma will undergo 3D total body photography and dermoscopy at the clinic every 12 months. In some instances, the dermatologist may wish to see some participants return in 6 months’ time to monitor any changes in suspicious skin lesions.

3. Very High Risk Group
Participants identified as having very high risk of melanoma will undergo 3D total body photography and dermoscopy at the clinic every 6 months for the duration of the study. In some instances, the dermatologist may wish to see some participants return in 3 months’ time to monitor any changes in suspicious skin lesions.

All participants will complete 12-monthly follow-up questionnaires about their sun behaviour, skin checks and quality of life.
Intervention code [1] 315574 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321396 0
Number and type of skin cancers, as assessed by artificial intelligence and pathology reports
Timepoint [1] 321396 0
Baseline, 12 months after baseline (primary timepoint), 24 months after baseline and 36 months after baseline
Primary outcome [2] 322155 0
Number and type of skin cancer precursor lesions, as assessed by artificial intelligence and pathology reports
Timepoint [2] 322155 0
Baseline, 12 months after baseline (primary timepoint), 24 months after baseline and 36 months after baseline
Secondary outcome [1] 374972 0
Assess participants' health-related quality of life using the Assessment of Quality of Life-4D (AQoL-4D) questionnaire
Timepoint [1] 374972 0
Baseline, 12 months after baseline, 24 months after baseline and 36 months after baseline
Secondary outcome [2] 374973 0
Assess participants' sun protection behaviour using a validated questionnaire used in previous similar studies, known as the Sun Behaviour and Health Questionnaire (REFERENCE: Koh U, Janda M, Aitken JF, Duffy DL, Menzies S, Sturm RA, et al. 'Mind your Moles' study: protocol of a prospective cohort study of melanocytic naevi. BMJ open. 2018;8(9):e025857).
Timepoint [2] 374973 0
Baseline, 12 months after baseline, 24 months after baseline and 36 months after baseline
Secondary outcome [3] 377229 0
Model potential cost savings to the patient and health care system associated with a more targeted and accurate screening approach compared to the current ad hoc approach using patient out-of-pocket costs from study-specific questionnaire and audit of Medicare data.
Timepoint [3] 377229 0
36 months after baseline
Secondary outcome [4] 377525 0
Assess skin cancer-related quality of life for those with a previous skin cancer diagnosis using the Skin Cancer Quality of Life Impact Tool (SCQOLIT)
Timepoint [4] 377525 0
Baseline, 12 months after baseline, 24 months after baseline and 36 months after baseline

Eligibility
Key inclusion criteria
1. Aged 18 years or older
2. Willing to attend clinic visits
3. Has a regular medical practitioner that can be listed for contact by the study team
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
No other exclusion criteria, apart from opposite of the inclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 15313 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 15314 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [3] 15316 0
Cairns Base Hospital - Cairns
Recruitment hospital [4] 15317 0
Mount Isa Base Hospital - Mount Isa
Recruitment hospital [5] 15318 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [6] 15319 0
Westmead Hospital - Westmead
Recruitment hospital [7] 15320 0
The Poche Centre, Melanoma Institute Australia - North Sydney
Recruitment hospital [8] 15321 0
The Alfred - Melbourne
Recruitment hospital [9] 15322 0
Skin and Cancer Foundation - Carlton
Recruitment hospital [10] 15323 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [11] 15324 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [12] 19817 0
The Townsville Hospital - Douglas
Recruitment hospital [13] 19818 0
Bass Coast Regional Health - Wonthaggi
Recruitment postcode(s) [1] 28623 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 28624 0
4575 - Birtinya
Recruitment postcode(s) [3] 28626 0
4870 - Cairns
Recruitment postcode(s) [4] 28627 0
4825 - Mount Isa
Recruitment postcode(s) [5] 28628 0
2050 - Camperdown
Recruitment postcode(s) [6] 28629 0
2145 - Westmead
Recruitment postcode(s) [7] 28630 0
2060 - North Sydney
Recruitment postcode(s) [8] 28631 0
3004 - Melbourne
Recruitment postcode(s) [9] 28632 0
3053 - Carlton
Recruitment postcode(s) [10] 28633 0
3550 - Bendigo
Recruitment postcode(s) [11] 34505 0
4814 - Douglas
Recruitment postcode(s) [12] 34506 0
3995 - Wonthaggi

Funding & Sponsors
Funding source category [1] 303824 0
Charities/Societies/Foundations
Name [1] 303824 0
Australian Cancer Research Foundation
Address [1] 303824 0
Suite 2, Level 3
77 King Street
Sydney, NSW 2000
Country [1] 303824 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia, QLD 4072
Country
Australia
Secondary sponsor category [1] 304004 0
University
Name [1] 304004 0
The University of Sydney
Address [1] 304004 0
The University of Sydney
Sydney, NSW 2006
Country [1] 304004 0
Australia
Secondary sponsor category [2] 304629 0
University
Name [2] 304629 0
Monash University
Address [2] 304629 0
Monash University
Melbourne, VIC 3800
Country [2] 304629 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304338 0
Metro South Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 304338 0
Translational Research Institute Level 7
37 Kent Street
Woolloongabba, QLD 4102
Ethics committee country [1] 304338 0
Australia
Date submitted for ethics approval [1] 304338 0
12/09/2019
Approval date [1] 304338 0
12/12/2019
Ethics approval number [1] 304338 0

Summary
Brief summary
The purpose of this study is to conduct three-dimensional total body photography to monitor skin lesions and improve the early detection of melanoma and other skin cancers.

Who is it for?
You may be eligible for this study if you are aged 18 or over and have a regular doctor. Note, that you do not need to have been diagnosed with skin cancer or be at risk of skin cancer to participate in this study.

Study details
All participants will have three-dimensional total body photography (excluding skin beneath underwear and scalp) to create a record of all pigmented and non-pigmented skin lesions. These scans will happen at various frequencies over the 3-year study period, depending on the participant’s melanoma risk group. The risk group is determined by completing a questionnaire to assess your risk of developing melanoma. As part of this study, all participants will complete yearly questionnaires about their sun behaviour, quality of life and skin cancer history.

It is hoped this research will improve identification and tracking of skin lesions (including potential melanomas) and reduce appointment times and healthcare costs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 96598 0
Prof H. Peter Soyer
Address 96598 0
The University of Queensland Diamantina Institute
Translational Research Institute
37 Kent Street
Woolloongabba, QLD 4102
Country 96598 0
Australia
Phone 96598 0
+61 07 3443 8017
Fax 96598 0
Email 96598 0
p.soyer@uq.edu.au
Contact person for public queries
Name 96599 0
Miss Caitlin Horsham
Address 96599 0
Centre of Health Services Research
Building 33 of Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba, QLD 4102
Country 96599 0
Australia
Phone 96599 0
+61 07 3176 4595
Fax 96599 0
Email 96599 0
c.horsham@uq.edu.au
Contact person for scientific queries
Name 96600 0
Dr Uyen Koh
Address 96600 0
The University of Queensland Diamantina Institute
Translational Research Institute
37 Kent Street
Woolloongabba, QLD 4102
Country 96600 0
Australia
Phone 96600 0
+61 07 3443 8019
Fax 96600 0
Email 96600 0
u.koh@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will be de-identified, collated and published.
What supporting documents are/will be available?
No other documents available
Summary results
No Results