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

Azienda Ospedaliero-Universitaria di Modena

Status: Completed

Conditions: Cutaneous Melanoma

Treatments: Device: Clinical, dermoscopy and Reflective confocal microscopy evaluations; Device: Clinical, dermoscopy evaluations

Study type: Interventional

Funder types: Other

Identifiers

NCT04789421

3844/C.E. (Other Identifier)

NET-2011-02347213

Details and patient eligibility

About

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.

Enrollment: 3,248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.).

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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3,248 participants in 2 patient groups, including a placebo group

Arm 1 (interventional)

Active Comparator group

Description:

Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation.

Treatment:

Device: Clinical, dermoscopy and Reflective confocal microscopy evaluations

Arm 2 (control)

Placebo Comparator group

Description:

Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused.

Treatment:

Device: Clinical, dermoscopy evaluations