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Clinical surveillance standard of care with addition of 2D or 3D Melanoma Surveillance Photography and digital dermoscopy.

Clinical surveillance standard of care without Melanoma Surveillance Photography.

Total body imaging using 2D or 3D Melanoma Surveillance Photography plus digital dermoscopy.

2D or 3D Melanoma Surveillance Photography

Victoria Mar

This randomised controlled trial will investigate the role of melanoma surveillance photography (MSP) in the surveillance of patients at high or ultra-high risk of melanoma. MSP is a comprehensive method of melanoma monitoring which includes total body photography and digital dermoscopy which is performed at prescribed intervals. The study will test whether participants under surveillance with MSP have less unnecessary biopsies (false positives) compared to those without MSP. Participants will be Australian residents with a new diagnosis of primary melanoma, who have multiple naevi and are at high or ultra-high risk of developing melanoma. Participants will be randomised 1:1 to either groups.

It is hypothesised that those randomised to surveillance with MSP will have better patient outcomes. Improved diagnostic performance as measured by the number of unnecessary biopsies will be the primary outcome measure.

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.

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.

Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients

To estimate the benefit of MSP in high risk patients prior to a melanoma diagnosis, amongst participants who would have been classified as 'high risk' at the time of their primary melanoma, this sub-study will compare:

i) Breslow thickness of the primary melanoma at entry into this trial, and ii) Biopsy rates prior to diagnosis

Approximately 100 paired sets of 3D surveillance and digital dermoscopy images (baseline and follow-up) taken from patients in the intervention arm, will be sent to 10 participating study doctors (both GPs and dermatologists; all 100 pairs sent to all 10 doctors) for teledermatology assessment. The study doctors will assess the images with respect to whether they have a melonama present or not. Images will be selected randomly from amongst patients accrued to the main study for this telediagnosis validation study. Approximately 30% of these will include an image of a melanoma confirmed by histopathology (gold standard) during the trial. This substudy will not affect patient care but will assess diagnostic performance (sensitivity and specificity) in the teledermatology setting compared to the en-face clinical setting in order to validate the use of telediagnosis in routine care.

The primary outcome is the diagnostic performance of surveillance for melanoma, expressed as the number of false positive biopsies per patient over a 24-month period.

Standard health economic cost-effectiveness measures.

Assessment of Quality of Life (AQOL-8D) questionnaire for calculation of quality-adjusted life years (QALYs). Minimum score per each of 8 questions is 1; maximum score is 5, where higher score represents worse outcomes. Scores may be aggregated to provide an overall index of the health state utility per participant, where higher scores indicate worse quality of life outcomes.

European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), Fear of Cancer Recurrence - short form (FCR4) and a purpose-designed patient acceptability scale will be utilised to synthesise a single endpoint measure for patient anxiety. Value range is 0 to 100, where higher values represent greater anxiety (worse outcomes).

Monash University

University of Sydney

The University of Queensland

Melanoma and Skin Cancer Trials Limited

Symptoms and General Pathology

Facies

Every patient will be evaluated by an in person dermatologist present at the screening.

In-person dermatology evaluation

Every patient will be evaluated online via a store and forward teledermatology modality.

Store-and-forward teledermatology evaluation

April W Armstrong, MD, MPH

The purpose of this study is to determine the diagnostic and management concordance of face-to-face dermatologist versus a store-and-forward teledermatologist at a skin cancer screening event.

The investigators' hypotheses include the following:

1. Compared to in-person assessment, store-and-forward teledermatology assessment will result in adequate diagnostic concordance.
2. Compared to in-person assessment, store-and-forward teledermatology results in adequate management concordance.
3. The sensitivity and specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant will be similar to that of in-person evaluation.

Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event

Aggregated diagnostic concordance which is defined as the agreement of the in-person dermatologist's principle diagnosis with the teledermatologist's primary diagnosis or any of the differential diagnoses.

Diagnostic concordance between the in-person dermatologist and the teledermatologist for their primary diagnosis.

Diagnostic concordance between the in-person dermatologist and teledermatologist based on standard clinical diagnostic categories for each lesion.

The concordance between the in-person dermatologist and teledermatologist for the chosen management plan for each lesion.

The sensitivity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.

The specificity of store-and-forward evaluation to detecting lesions that are either premalignant or malignant.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Melanoma Surveillance Photography (MSP) to Improve Early Detection of Melanoma in Ultra-high and High Risk Patients	NCT04385732	Melanoma Skin Cancer Anxiety and Fea...	2D or 3D Melano...	18 Years -	Melanoma and Skin Cancer Trials Limited
Evaluation of Store-and-Forward Teledermatology Versus a Face-to-Face Assessment During a Skin Cancer Screening Event	NCT01820234	Skin Cancer Screening Telemedicine	In-person derma... Store-and-forwa...	18 Years -	University of California, Davis

Spots Global Cancer Trial Database for teledermatology