‘Mind your Moles’ study: protocol of a prospective cohort study of melanocytic naevi

Abstract

IntroductionHaving many melanocytic naevi or ‘moles’ on the skin is the strongest predictor of melanoma; thus, much can be learnt from investigating naevi in the general population. We aim to improve the understanding of the epidemiology and biology of naevi by conducting a 3-year prospective study of melanocytic naevi in adults.Methods and analysisThis is a population-based cohort study of melanocytic naevi in 200 adults aged 20–69 years recruited via the Australian electoral roll. At baseline, participants will complete a questionnaire on their sun behaviour and health and undergo a clinical examination. Three-dimensional (3D) total-body photography will be used to record the images of skin lesions. Pigmented naevi will be analysed in terms of number, diameter, colour and border irregularity using automated analysis software (excluding scalp, beneath underwear and soles of feet). All naevi ≥5 mm will be recorded using the integrated dermoscopy photographic system. A saliva sample will be obtained at baseline for genomic DNA analysis of pigmentation, naevus and melanoma-associated genes using the Illumina HumanCoreExome platform. The sun behaviour and health follow-up questionnaire, clinical examination and 3D total-body photography will be repeated every 6 months for 3 years. The first 50 participants will also undergo manual counts of naevi ≥2 mm and ≥5 mm at baseline, 6-month and 12-month follow-ups. Microbiopsy and excision of naevi of research interest is planned to commence at the 18-month time point among those who agree to donate samples for detailed histopathological and molecular assessment.Ethics and disseminationThis study was approved by the Metro South Health Human Research Ethics Committee in April 2016 (approval number: HREC/16/QPAH/125). The findings will be disseminated through peer-reviewed and non-peer-reviewed publications and presentations at conferences.

Early detection of melanoma: a consensus report from the Australian Skin and Skin Cancer Research Centre Melanoma Screening Summit

“…[41][42][43] These technology advances could inform a more systematic approach to melanoma screening in the future, but their utility in practice needs, including ensuring equitable access and training of the primary care workforce, requires further evaluation. [44][45][46][47] Prospective studies are needed to assess how to optimally integrate these advanced imaging systems with more complex diagnostic categories, on various skin types, and also to determine how best to use artificial intelligence algorithms to enhance clinical decision making without introducing bias. 42,48…”

Evaluation of the efficacy of 3D total-body photography with sequential digital dermoscopy in a high-risk melanoma cohort: protocol for a randomised controlled trial

“…Saliva samples collected using Oragene DNA self-collection kit. Methods for sample processing described previously 27…”

“…Self-administered, previously validated sun behaviour questionnaire to record sun protective behaviour, sun exposure, sunburn history, personal and family skin cancer history, and relevant demographic information 27 30…”

“…Questionnaire data will be prepared according to each scale’s manual and standard procedures 27–33. Total and subscale scores will be computed and tested for normality.…”

A minimally invasive clinical model to test sunscreen toxicity based on oxidative stress levels using microbiopsy and confocal microscopy – a proof of concept study

“…We rationalized, therefore, to investigate the feasibility of a minimally invasive model to test tissue responses to topical products using our microsampling technology. We developed and validated a novel skin device called 'Microbiopsy' that enables minimally invasive skin sampling from volunteers without the need for anaesthesia or sutures [9,[20][21][22][23][24][25][26]. The microbiopsy needle can harvest around few hundred cells with a minimal risk to the volunteers [27].…”