None listed
Conditions
Brief summary
This study aims to identify genetic differences and dermatological characteristics that pose greater risk for development of skin cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are either undergoing targeted therapies and/or immunotherapies at the Cancer Services (PA Hospital) for stage III or IV melanoma OR if you are considered to be at a high risk of melanoma. Study details: This is an observational prospective study (no additional treatment) on the natural history of naevi in advanced melanoma patients receiving treatment. This will include observations of molecular and genetic differences associated with changing naevi and melanoma risk. Patients will be followed up every 4 months for 1 year (4 visits in total) with 3D whole body photography and dermoscopy of all naevi larger than 3mm. The germline genotype is determined by collecting saliva together with baseline demographic data along with images. During follow up visits, naevi which show clinical and dermoscopic changes in pigmentation are sampled using a microbiopsy device. DNA and RNA can be isoalted from these samples for somatic genotyping. The same naevus can be sampled several times over the course of its growth and following visits. Additional shave biopsies (up to 3) will also be taken for comparative purposes. It is hoped that this study will lead to better understanding of genetic and phenotypic characteristics that lead to high risk of melanoma development and that may then assist in early diagnosis and preventative behaviours of skin cancer.
Interventions
Participants will undergo total body examination and mole count, including eye/hair/skin colour and density of freckling. In addition to total body photography, dermoscopic mole images will be captured using a digital dermoscope. We will require a saliva sample for genetic analysis. Study participants will be followed up every 4 months for one year (4 visits in total). If participants have any moles that are considered atypical by their dermatologist and therefore require excision, we would lik
Participants will undergo total body examination and mole count, including eye/hair/skin colour and density of freckling. In addition to total body photography, dermoscopic mole images will be captured using a digital dermoscope. We will require a saliva sample for genetic analysis. Study participants will be followed up every 4 months for one year (4 visits in total). If participants have any moles that are considered atypical by their dermatologist and therefore require excision, we would like to have residual tissue provided following clinical evaluation and diagnosis by the pathologist. this tissue sample would be used for further genetic analysis. During follow up visits, naevi which show clinical and dermoscopic changes in pigmentation are sampled using a microbiopsy device. DNA and RNA can be isolated from these samples for somatic genotyping. We will also take shave biopsies of other lesions (up to 3) for histopathology and genetic analysis.
Sponsors
The University of Queensland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Cohort 1: melanoma patients with stage III and IV enrolled for treatment with targeted therapies and/or immunotherapies at the Cancer Services (PA Hospital). Baseline visit must be within 6 weeks of beginning melanoma treatment. Cohort 2: participants considered high risk for melanoma under at least one of the following three subcategories; a) Personal history of melanoma (stage I-IV, not in situ) b) First degree family history of melanoma (stage I-IV, not in situ) c) Atypical mole syndrome, defined as grater then 100 naevi, 6 (or more) atypical naevi (confirmed using dermoscopy), AND at least 1 naevus 8 mm (or greater) in dimension.
Exclusion criteria
All participants must be able to give informed consent. All participants are asked to commit to 4 visits to the PA Hospital to participate in the trial over a 12 month period (months 0, 4, 8 and 12), as long as they are able to (Participants can withdraw from the study at any time for any reason). Participants in cohort 2 must not be currently undergoing any treatment for melanoma.
Outcome results
None listed