NCT04789421

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,248 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria di Modena · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cutaneous Melanoma

Interventions

Type	Name	Description
DEVICE	Clinical, dermoscopy and Reflective confocal microscopy evaluations	Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.
DEVICE	Clinical, dermoscopy evaluations	Dermoscopy and clinical dermatological evaluation only

Timeline

• Start date: 2016-03-01
• Primary completion: 2020-02-28
• Completion: 2020-03-16
• First posted: 2021-03-09
• Last updated: 2021-03-09

Regulatory

• FDA-regulated device study