MoleGazer Development Feasibility Study
Melanoma (Skin), Moles Multiple Benign
About this trial
This is an interventional other trial for Melanoma (Skin)
Eligibility Criteria
Inclusion Criteria:
- Participant is willing and able to give informed consent for participation in the study
- Male or Female, aged 18-80 years old
In addition for Group A:
- Willing to attend for additional study visits and total body photography imaging
High-risk melanoma patients including:
- Dysplastic / atypical naevus syndrome (> 60 moles +/- personal history of melanoma)
- Family history of melanoma
- Past history of at least two primary melanoma or melanoma-in situ
- At least 3 first-degree or second-degree relatives with prior melanoma
- CDKN2A or CDK4 germline mutation
- Individuals with multiple naevi (>25) who are immunosuppressed from any cause (e.g. organ transplant recipients, chronic lymphocytic leukaemia, etc.)
In addition for Group B:
● Has previously had total body photography imaging OR will have total body photography as part of standard care
Exclusion Criteria:
The participant may not enter the study if ANY of the following apply:
- Patient unable to consent
- Patient with active malignancy affecting any organ and receiving any cancer-specific treatment
- Poor mobility / unable to hold recommended positions for standard TBP imaging
- Individuals who do not understand English
In addition for Group A:
● Unable to attend for three-monthly study visits
Sites / Locations
- Churchill HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Group A: Time series
Group B: Baseline cohort
Individuals at high risk of developing melanoma will be invited to attend for sequential TBP imaging, full body skin examination by a Dermatologist and completion of a case report form (CRF) every three months for two years. At the end of the study participants will also be invited to complete a feasibility questionnaire
All patients who undergo standard care and are selected for total body photography (TBP) imaging will be invited to consent to this group. Any individuals who have had previous TBP imaging will also be eligible to enter Group B of this study. A baseline CRF will be completed and a participant feasibility questionnaire. There will be no additional images taken for the purposes of the study and no additional clinic visits in relation to this part of the study. However, individuals who consent to Group B will also agree to share any future TBP images taken in the department over the next two years so that any sequential images can also be included in the analysis