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

Not Applicable

Completed

• Conditions: Cutaneous Melanoma
• Interventions: Device: Clinical, dermoscopy and Reflective confocal microscopy evaluations; Device: Clinical, dermoscopy evaluations

• Registration Number: NCT04789421
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Modena

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03-01
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-16
• Status Verified: 2021-03
• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-08
• Last Update Submitted: 2021-03-08
• Study First Posted: 2021-03-09
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3248

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.).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1 (interventional)	Clinical, dermoscopy and Reflective confocal microscopy evaluations	Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation.
Arm 2 (control)	Clinical, dermoscopy evaluations	Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused.

Primary Outcome Measures

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

Secondary Outcome Measures

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