Background: Melanoma surveillance photography (MSP), comprising two- or three-dimensional total body photography (TBP) with tagged digital dermoscopy performed at prescribed intervals, has the potential to reduce unnecessary biopsies and enhance early detection of melanoma. However, high quality evidence is needed to support policy decisions related to subsidisation on the Medicare Benefits Schedule, clinical guidelines and standard of care for surveillance of high-risk individuals.
Aim: To evaluate the clinical impact of using MSP for the surveillance of individuals with a previous melanoma and at high risk of developing a new melanoma.
Methods: We conducted an unblinded, multi-site, parallel-arm randomised controlled trial. Participating sites (n=10), including regional and metropolitan, primary care and tertiary institutions, recruited 670 participants through state cancer registries in Queensland and Victoria and via clinician referrals in Queensland, Victoria and New South Wales, between March 2021 and April 2023. Eligible participants had a previous primary cutaneous melanoma diagnosis within the past 24 months, were not undergoing active surveillance with TBP, had ‘some/many’ naevi and >5% predicted 10-year risk of developing a new primary melanoma, based on a risk prediction tool developed for this study. Participants were randomised 1:1 to receive either MSP in addition to their routine clinical surveillance (intervention group) or routine clinical surveillance alone (control group), and were followed for 2 years. The primary outcome was the number of unnecessary biopsies (i.e. false positives), defined as biopsies of melanocytic lesion performed because of suspected melanoma, where histopathology did not confirm melanoma. Data were collected from clinical records, pathology reports, participant diaries, questionnaires, and linked Medicare Benefits Schedule and Pharmaceutical Benefits Scheme records.
Results: We will present the results for the primary outcome and diagnostic performance endpoints from the trial, comparing the intervention and control arms for the number of excisions, benign to malignant ratio, the total number of excisions, and Breslow thickness of on-study melanomas.
Trial registration: ClinicalTrials.gov NCT04 385732