Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000450415
Ethics application status
Approved
Date submitted
1/03/2016
Date registered
7/04/2016
Date last updated
26/05/2022
Date data sharing statement initially provided
26/05/2022
Date results provided
26/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Natural history of naevi and the use of dermatoscope for skin self assessment of naevi in adults in Brisbane, Australia
Scientific title
A prospective population-based cohort study of the natural history of naevi and the use of a dermatoscope for skin self assessments of naevi in adults living in Brisbane, Australia
Secondary ID [1] 288670 0
HPS002
Universal Trial Number (UTN)
U1111-1180-2408
Trial acronym
BERNS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Melanoma 297864 0
Condition category
Condition code
Skin 298038 298038 0 0
Other skin conditions
Cancer 298039 298039 0 0
Malignant melanoma
Human Genetics and Inherited Disorders 298040 298040 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be required to attend the Princess Alexandra Hospital, Clinical Research Facility for an appointment that will involve questionnaires, skin examination and mapping of skin naevi using 3D total body photography in their underwear. The participant will need to provide a saliva sample in order to sequence their genomic DNA. The initial appointment is expected to take between 1 to 2 hours, depending on how many naevi the participant has. We will also lend some participants (approximately 60) a dermatoscope attachment for their phone to image 2 moles identified by the clinician at two time-points. Participants will need to own a compatible smart phone in order to receive the dermatoscope attachment. The dermatoscope attachment allows participants to take dermoscopy quality image of moles. Instructions will be provided for the assessment. These participants will be asked to complete a questionnaire on their experience using the dermatoscope.
We will also require participants to attend follow up visits every 6 months for the duration of the study. These visits will involve a repeat of 3D total body photography to monitor skin naevi changes. We will also ask participants to consider donating benign naevi for excision and any residual tissue from suspicious lesions recommended for excision. Tissue donated will be used for additional molecular analysis of gene products and proteins known to be involved in melanoma development and progression. This aspect of the study is optional, and will not affect their eligibility for the trial. Follow up appointments will take also take 1 to 2 hours.
Intervention code [1] 294129 0
Early detection / Screening
Comparator / control treatment
Approximately 60 participants will be provided with a dermatoscope phone attachment and asked to monitor 2 moles specified by the research team. Half the participants will be assigned naevi in easy-to-see body areas, and the other half will be asked to image naevi in hard-to-see body areas.
Control group
Active

Outcomes
Primary outcome [1] 297553 0
To record the number of naevi on participants, including details relating to size and changes of naevi between timepoints (i.e. has the naevi changed size or become irregular), using 3D total body photography and dermoscopy.
Timepoint [1] 297553 0
6 monthly visits for a period of 3 years (7 visits in total).
Primary outcome [2] 297554 0
Correlate naevi counting data (obtained from 3D total body photography) and other phenotype, genotype and dermoscopic factors prevalent among common and dysplastic naevi.
Genotype is assessed by saliva sample and skin samples (to provide both germline and somatic DNA).
Phenotype and dermoscopic factors are assessed using 3D total body photography and individual dermoscopic images of naevi.
This is a composite primary outcome.
Timepoint [2] 297554 0
6 monthly visits for a period of 3 years (7 visits in total).
Secondary outcome [1] 321397 0
To assess the methods of skin self-examinations used by participants, assessed by semi-structured interview process,
Timepoint [1] 321397 0
6 monthly visits for a period of 3 years (7 visits in total).
Secondary outcome [2] 321398 0
examine the accuracy of the microbiopsy (a micro-medical device for sampling skin cells), by comparing results of genetic analysis of sample with standard histopathology results of lesion sampled (which is excised after microbiopsy is taken.)
Timepoint [2] 321398 0
this may occur at any (but not all) 6 monthly visits for a period of 3 years (7 visits in total).
Secondary outcome [3] 322605 0
To determine the feasibility of mobile teledermoscopy for the self-imaging of easy-to-see naevi versus difficult-to-see naevi. The images taken by the participants will be assessed for image quality in terms of lighting, background colour, field of view, image orientation, resolution, and focus and depth of field. We will compare the image quality performance between the group monitoring easy-to-see naevi and the group monitoring difficult-to-see naevi using t-tests.
Timepoint [3] 322605 0
6 monthly visits for a period of 3 years (7 visits in total).

Eligibility
Key inclusion criteria
Ability to provide informed consent, at least one naevus and willingness to attend research examination follow up visits.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
For the cross sectional data, descriptive statistical analyses including counts and proportions will be used to describe the number of naevi (> 2mm, > 5mm) and the average number of dysplastic naevi by participant sex, age and body site. Participants will be grouped by phenotype, or pigmentation/naevus genotype, and the number and type of naevi by body site in each of these subgroups will be summarised. Descriptive statistics will also be used to summarise dermoscopic features of naevi by body site. Depending on the distribution of the outcomes, parametric or non-parametric approaches to bivariate analyses will be considered.

To assess the unadjusted and adjusted strength of association between participants’ phenotypic or genotypic characteristics and naevi outcomes, linear or logistic regression models will be fitted, depending on whether the outcome is used in continuous or categorical format. These models will be conducted in crude and adjusted form to ascertain the independent contribution of explanatory factors (for example skin type) on the outcomes. Interaction terms will also be fitted where appropriate (for example phenotype and genotype) to explain naevus counts or distributions.

At each timepoint the cross sectional analyses will be repeated, and in addition changes in numbers of naevi over time will be calculated. Repeated measures models will be built to assess changes in naevus number, type or severity over time.

For the randomised controlled skin self-examination trial, success of randomisation will be assessed by providing a table of characteristics by participant randomised to the two groups. To determine the feasibility of mobile teledermoscopy for the self-imaging of easy-to-see naevi versus difficult-to-see naevi. The images taken by the participants will be assessed for image quality in terms of lighting, background colour, field of view, image orientation, resolution, and focus and depth of field. We will compare the image quality performance between the group monitoring easy-to-see naevi and the group monitoring difficult-to-see naevi using t-tests.

To address the research question of how well do clinical molecular and genetic changes of in-vivo and ex-vivo microbiopsies as assayed by Next Generation exome sequencing reflect the histopathological outcomes, we will use measures of sensitivity and specificity, as well as area under the curve calculations to compare the classification quality of microbiopsy against gold standard clinical or histopathological workup.

No formal sample size calculations was performed

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2016
Actual
5/10/2016
Date of last participant enrolment
Anticipated
3/12/2018
Actual
30/05/2017
Date of last data collection
Anticipated
1/06/2020
Actual
15/06/2020
Sample size
Target
200
Accrual to date
Final
215
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5368 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 12823 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 293027 0
Government body
Name [1] 293027 0
National Health and Medical Research Council (NHMRC)
Country [1] 293027 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
TRI, 37 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 291803 0
None
Name [1] 291803 0
none
Address [1] 291803 0
Country [1] 291803 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294538 0
Metro South Health HREC
Ethics committee address [1] 294538 0
Ethics committee country [1] 294538 0
Australia
Date submitted for ethics approval [1] 294538 0
10/02/2016
Approval date [1] 294538 0
21/04/2016
Ethics approval number [1] 294538 0
HREC/16/QPAH/125

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 64058 0
Prof H. Peter Soyer
Address 64058 0
Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102
Country 64058 0
Australia
Phone 64058 0
+61 7 3443 8017
Fax 64058 0
+61 7 3443 7779
Email 64058 0
[email protected]
Contact person for public queries
Name 64059 0
Clare Primiero
Address 64059 0
Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102
Country 64059 0
Australia
Phone 64059 0
+61 7 3443 7496
Fax 64059 0
+61 7 3443 7779
Email 64059 0
[email protected]
Contact person for scientific queries
Name 64060 0
Clare Primiero
Address 64060 0
Dermatology Research Centre, School of Medicine, The University of Queensland
TRI, 37 Kent Street, Woolloongabba QLD 4102
Country 64060 0
Australia
Phone 64060 0
+61 7 3443 7496
Fax 64060 0
+61 7 3443 7779
Email 64060 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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.