Finding studies
Finding studies
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Lead
Melanoma and Skin Cancer Trials Limited
With
The primary aim is to test whether melanoma surveillance with MSP, comprising either 2D or 3D TBP tagged with digital dermoscopy, compared to clinical surveillance without MSP, results in improved diagnostic performance, specifically reduced number of unnecessary biopsies (i.e. false positives due to an excision or biopsy of a lesion being performed to diagnose melanoma and that lesion being identified on pathology as benign), in high (and very high) risk individuals whose risk is contributed to by high naevus counts. The secondary aims are to: 1. Evaluate whether MSP: 1. Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives) 2. Improves health-related quality of life, patient satisfaction, and reduces patient anxiety 3. Reduces costs to patients and health care system 2. Evaluate the safety and acceptability of MSP 3. Evaluate benefit of MSP in high risk patients prior to a primary melanoma diagnosis (Sub-study 1) 4. Evaluate diagnostic performance of tele-dermatology compared to en-face clinical visits (Sub-study 2). Investigators hypothesise that for ultra-high and high risk patients with multiple naevi, clinical surveillance with melanoma surveillance photography (compared to without MSP) will lead to better patient outcomes, in particular a reduction in the number of unnecessary biopsies (i.e. false positives) as a measure of diagnostic performance. Secondary hypotheses include that for ultra-high, and high risk patients with multiple naevi, clinical surveillance with MSP (compared to without MSP) will lead to: 1. Reduction in the number of misclassified melanoma malignancies (i.e. false negatives); 2. Reduction in the number of misclassified melanocytic and keratinocyte lesions combined; 3. Improved quality of life; and 4. Favourable health economic outcomes.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
