Advanced Non-invasive Diagnostics for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic and Economic Management

Study Overview
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Brief Summary
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The incidence of cutaneous melanoma (MM) is increasing worldwide. The best therapeutical solution for MM is early diagnosis and efforts over the last 50 years have been directed towards early and precise diagnoses. Dermoscopy has improved diagnostic accuracy compared to the naked eye, but is limited by an associated higher number of unnecessary excisions. Reflectance confocal microscopy (RCM) is a novel technique enabling in vivo examination of the skin at cellular-level resolution, with excellent diagnostic accuracy. This study hypothesis is that the systematic application of RCM in the triage and management of patients suspicious for skin cancer, may improve diagnostic accuracy and reduce the number of unnecessary biopsy. Reducing the burden of unnecessary surgery excisions should benefit the health system, both in saving surgical and pathology procedural associated costs and reducing the overwhelming waiting lists for excisions and consequent risk for delayed diagnoses.

Official Title
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Multicenter, Randomised Study of the Impact of Advanced, Non-invasive Diagnostic Instrumentation for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic Pathways and an Economic-management Perspective

Conditions
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Cutaneous Melanoma

Intervention / Treatment
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* Device: Clinical, dermoscopy and Reflective confocal microscopy evaluations
* Device: Clinical, dermoscopy evaluations


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), >= 18 years old Exclusion Criteria: (i) the presence of an unequivocal aspect of melanoma or of any other malignant skin cancer, (ii) lesion located on a skin area where reflectance confocal microscopy cannot be performed (for example: skin folds, mucosa, etc.), (iii) lesion larger than 2 cm in its largest diameter (iv) lesion where RCM examination is hampered for over the 30% of its surface (for example, for presence of crusting, oozing, erosion, ulceration, etc.).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: A two-arm prospective, multi-center study of the triage of patients with equivocal skin lesions suspicious for melanoma, compared with the standard of care (i.e. clinical and dermoscopic examination). A 1:1 randomization into the interventional or control arms occurred at the time of enrolment. Arm 1 (interventional) included lesions that were evaluated with RCM with management decisions taken according with overall information (2 possible outcomes: excision or digital monitoring. Arm 2 (control) included lesions that were not evaluated with RCM, with management decisions taken according to clinical and dermoscopy evaluations only (2 possible outcomes: excision or follow-up).
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 (interventional)<br>Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation. | Device: Clinical, dermoscopy and Reflective confocal microscopy evaluations<br>* Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.<br>|
| Placebo Comparator: Arm 2 (control)<br>Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused. | Device: Clinical, dermoscopy evaluations<br>* Dermoscopy and clinical dermatological evaluation only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number needed to excise (NNE) | Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis | 03/2016 - 02/2020 | 
| Early diagnosis | Measure the breslow index of excised lesions | 03/2016 - 02/2020 | 
| RCM diagnostic sensibility and sensitivity | Diagnostic sensibility of RCM in identifying cutaneous melanoma among equivocal lesions suspicious for melanoma (without clear demoscopy criteria for melanoma) | 03/2016 - 02/2020 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Head and neck pigmented lesions | Diagnostic accuracy of pigmented head and neck lesions where differential diagnosis is difficult to achieve and improper treatments (cryotherapy, laser, radiofrequency). | 03/2016 - 02/2020 | 
| Diagnostic accuracy of non melanoma skin cancer | Pre-and intra-operative imaging for surgical margins | 03/2016 - 02/2020 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic accuracy, number needed to excise, reflectance confocal microscopy, histopathology, dermoscopy, early diagnosis