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Addition of dermoscopy to conventional naked-eye examination in melanoma screening: a randomized study☆

https://doi.org/10.1016/j.jaad.2003.09.009Get rights and content

Abstract

Objective

We sought to assess the difference in lesion management between combined examination (naked-eye and dermoscopy) and conventional naked-eye examination in evaluations for melanoma; and to assess the impact on patient treatment of facilities for digital follow-up of diagnostically equivocal lesions.

Methods

We conducted a randomized, controlled trial at a pigmented lesion clinic in a university hospital. A total of 938 consecutive subjects presenting between November 1, 2001, and March 31, 2002, were eligible and 25 were excluded because they were younger than 12 years of age; hence 913 subjects were enrolled. Participants were randomized to combined examination with mandatory excision of equivocal lesion (arm B) and with possibility of digital follow-up according to the clinician's decision (arm C), or to conventional naked-eye examination (mandatory excision of equivocal lesion) (arm A). The same pigmented lesion clinic staff examined all subjects.

Results

Combined examination determined a significant reduction in the percentage of patients referred for operation (9.0% vs 15.6%) (P = .013). When facilities for digital follow-up of equivocal lesions were available, the percentage of patients classified as harboring lesions difficult to diagnose increased (group C, 35.8%; group B, 17.8%; P < .01). About half of them were immediately referred for operation whereas the remainder submitted to second examination (digital follow-up). Two melanomas (1 in situ and 1 invasive, 0.40-mm thick) were diagnosed after second examination performed 6 months later. The number of melanomas eventually excised within the study were similar among the 3 allocation groups (3, 2, and 3, respectively).

Conclusions

the addition of dermoscopy to conventional naked-eye examination is associated with a significant reduction of number of pigmented skin lesions excised for diagnostic verification. The possibility of digital follow-up of equivocal lesions is associated with a not negligible occurrence of initial melanomas left unexcised until the second consultation.

Section snippets

Study population

The study population was a consecutive series of 913 subjects who sought specialized consultation for melanoma screening at the PLC of the University of Florence, Centre Italy, Florence, Italy, from November 1, 2001, to March 31, 2002. Melanoma detection rates and patterns of referral to the PLC have been reported elsewhere.9 Most of the subjects were resident in the city of Florence, Italy (56.3%), or in surrounding municipalities (38.4%), less frequently in other Tuscany, Italy, areas (3.7%)

Results

The study population consisted of 913 patients consecutively examined at the PLC (Table I). In all, 21 patients were not included because they were younger than 12 years, hence, were very unlikely to have melanoma according to incidence rates in the resident population of the Florence, Italy area.12

Discussion

To our knowledge, this is the first prospective, randomized trial aimed to investigate the impact of the addition of dermoscopy to conventional naked-eye examination in routine melanoma screening. In recent years, many studies on the possible role of dermoscopy in the diagnosis of pigmented skin lesions, including melanoma, have been reported.2, 3, 4 All of them, however, dealt with classification of lesions previously excised or planned for excision. Therefore, little is known about the effect

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☆

Supported by the Italian Ministry of Research (Cofin MIUR 2001).

Conflicts of interest: None identified.

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Copyright © 2004 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.