Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Anxiety and Fear
- Melanoma
- Skin Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The trial is an open-label, multi-site, parallel-arm randomised controlled trial. Participants meeting the eligibility criteria will be randomised 1:1 to either standard care or the intervention arm. Randomisation will be 1:1 to either Intervention or Control group stratified by high/ultra-high risk of 2nd primary melanoma, sex, 2D/3D imaging, GP/Dermatologist.Masking: None (Open Label)Primary Purpose: Diagnostic
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
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 accuracy, specifically reduced number of unnecessary biopsies (i.e. false positives due to a...
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 accuracy, 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: Test whether MSP: Results in improved sensitivity of doctors' diagnosis of melanoma (i.e. reduction in false negatives) Improves health-related quality of life, patient satisfaction, and reduces patient anxiety Reduces costs to patients and health care system Is cost effective compared with a strategy of no MSP Estimate the financial implications to Medicare of introducing MSP Evaluate diagnostic accuracy of tele-dermatology compared to en-face clinical visits. Evaluate the safety and acceptability of melanoma surveillance photography 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 accuracy. Pre-specified secondary outcomes will be sensitivity and specificity, thickness and stage at diagnosis of subsequent melanomas, quality of life, costs and cost-effectiveness.
Tracking Information
- NCT #
- NCT04385732
- Collaborators
- Monash University
- Investigators
- Principal Investigator: Victoria Mar Monash University and Alfred Health
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