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

Azienda Ospedaliero-Universitaria di Modena3,248 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Enrollment

3,248

Conditions

Cutaneous Melanoma

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.).

Outcomes

Primary Outcomes

Number needed to excise (NNE)

Measure the number of lesions needed to excise for a cutaneous melanoma diagnosis

Time frame: 03/2016 - 02/2020

Early diagnosis

Measure the breslow index of excised lesions

Time frame: 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)

Time frame: 03/2016 - 02/2020

Secondary Outcomes

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).

Time frame: 03/2016 - 02/2020

Diagnostic accuracy of non melanoma skin cancer

Pre-and intra-operative imaging for surgical margins

Time frame: 03/2016 - 02/2020