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Evaluation of targeted screening in high risk melanoma patients using: 3D full body imaging, genomic risk assessment and functional testing of gene variants.

Evaluation of the consumer acceptability and economic efficacy of targeted screening in high risk melanoma patients using: 3D full body imaging, genomic risk assessment and functional testing of gene variants.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000267257
Enrollment
314
Registered
2018-02-21
Start date
2018-04-16
Completion date
2019-10-01
Last updated
2024-08-05

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 will evaluate the effectiveness of targeted screening of people at high-risk of melanoma using 3D full body imaging and genomic risk assessment. Who is it for? You may be eligible to join this study if you have been diagnosed with melanoma before the age of 40 years old. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will receive standard care at the participants’ discretion which may involve regular skin checks from their own doctor. Participants in the other group will attend a screening program involving 6-monthly 3D full body imaging for 24 months and a once-off genetic testing for high-risk melanoma genes. We hypothesise our surveillance program using 3D whole body photography and genomic testing will be cost-effective, and will result in fewer excisions of benign lesions and earlier/smaller excision of malignant lesions than the control standard care group

Interventions

The intervention is a targeted screening program for people who are at high risk to melanoma. This screening program involves visits to the Clinical Research Facility at Princess Alexandra Hospital every 6 months for a period of 2 years (5 visits in total). At these visits participants will complete questionnaires (clinical examination form and 'melanoma surveillance - a patients perspective' questionnaire), they will donate a saliva sample for genetic sequencing (baseline visit only), and they

The intervention is a targeted screening program for people who are at high risk to melanoma. This screening program involves visits to the Clinical Research Facility at Princess Alexandra Hospital every 6 months for a period of 2 years (5 visits in total). At these visits participants will complete questionnaires (clinical examination form and 'melanoma surveillance - a patients perspective' questionnaire), they will donate a saliva sample for genetic sequencing (baseline visit only), and they will have 3D full body imaging done with further dermoscopic imaging of all naevi larger than 3mm. Participants will be seen by either a Dermatologist or a clinical research assistant trained by a dermatologist. A second Research Assistant will also be present at participant visits. Patient visits should take between 1-2 hours, depending on the amount of moles the participant has. All images taken at patient visits will be reviewed by a dermatologist. The saliva sample will be used for genetic analysis that will be used to identify genes associated with high risk of melanoma. This information will be used for further research into melanoma risk, but will not affect the intervention, i.e. participant visits will be the same regardless of genetic findings. We will also collect healthcare data for cost/benefit analysis A substudy will evaluate the feasibility of using telehealth services to review 3D full body imaging remotely for a clinical skin examination. Both the technical feasibility of the telehealth network, including interoperability with hospital image repositories and integrated electronic medical records will be evaluated, with addition to the accuracy and concordance of skin examinations between a in-person clinical skin check compared with a teledermatological diagnosis.

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
No

Inclusion criteria

1st round of recruitment: - diagnosed with multiple melanomas before the age of 40 2nd round of recruitment: - aged 40-65 with multiple melanomas 3rd round of recruitment: - diagnosed with single melanoma before the age of 40 4th round of recruitment; - Individuals considered high risk by a Dermatologist due to strong family history of melanoma, genetic status, and/or dysplastic naevi syndrome The different inclusion criteria at different rounds of recruitment are to ensure that those at highest risk to melanoma are given the opportunity to participate in the study. Other inclusion criteria includes: -ability to provide informed consent -willingness and ability to commit to a 24 months study including attending 5 visits to the CRF facility at Princess Alexandra Hospital

Exclusion criteria

Receiving current treatment for melanoma

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 5, 2026