Skip to content

Natural history of naevi and the use of dermatoscope for skin self assessment of naevi in adults in Brisbane, Australia

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000450415
Acronym
BERNS
Enrollment
215
Registered
2016-04-07
Start date
2016-10-05
Completion date
2017-05-30
Last updated
2022-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is about identifying what genetic differences and dermatological characteristics (such as form and structure of moles and eye/hair colour), are associated with skin cancers and who is at greatest risk. The study is also looking at how people conduct their own skin self-examinations. Who is it for? We will be contact people via letter off the Brisbane Electoral Roll. The letter will include a Information sheet and contact details in which the letter recipient can use to make an initial appointment to participate in the study. Study details: 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. We will also ask participants to conduct a skin self-examination every 3 months for the duration of the study (3 years). Half of the participants will be randomised to receive a dermatoscope attachment for their mobile phone to use in the self examinations. 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 eligibility for the trial.

Interventions

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 (approxi

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.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Ability to provide informed consent, at least one naevus and willingness to attend research examination follow up visits.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026