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

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

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 Overview

• Status: Completed
• Conditions: Cutaneous Melanoma
• Intervention / Treatment: Device: Clinical, dermoscopy and Reflective confocal microscopy evaluations; Device: Clinical, dermoscopy evaluations

• Study Type: Interventional
• Enrollment (Actual): 3248
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1 (interventional); 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; Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.
PLACEBO_COMPARATOR: Arm 2 (control); Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused.	Device: Clinical, dermoscopy evaluations; Dermoscopy and clinical dermatological evaluation only

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliero-Universitaria di Modena
• Investigators: Principal Investigator: Giovanni Pellacani, MD, Azienda Ospedaliera Modena

Publications and helpful links

General Publications

• Pellacani G, Farnetani F, Ciardo S, Chester J, Kaleci S, Mazzoni L, Bassoli S, Casari A, Pampena R, Mirra M, Lai M, Magi S, Mandel VD, Di Matteo S, Colombo GL, Stanganelli I, Longo C. Effect of Reflectance Confocal Microscopy for Suspect Lesions on Diagnostic Accuracy in Melanoma: A Randomized Clinical Trial. JAMA Dermatol. 2022 Jul 1;158(7):754-761. doi: 10.1001/jamadermatol.2022.1570.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2016
• Primary Completion (ACTUAL): February 28, 2020
• Study Completion (ACTUAL): March 16, 2020

Study Registration Dates

• First Submitted: March 5, 2021
• First Submitted That Met QC Criteria: March 8, 2021
• First Posted (ACTUAL): March 9, 2021

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: diagnostic accuracy; reflectance confocal microscopy; early diagnosis; histopathology; number needed to excise; dermoscopy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma; Skin Neoplasms
• Other Study ID Numbers: NET-2011-02347213; 3844/C.E. (OTHER: University-Hospital of Modena Provincial Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared on a sharing platform
• IPD Sharing Time Frame: Data will be available in 2021
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes