Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions

Recruiting now

Conditions studied: Melanocytic Nevi, Melanoma (Skin Cancer), Next Generation Sequencing (NGS)

In brief

This observational, prospective cohort study aims to evaluate the diagnostic relevance of Reflectance Confocal Microscopy (RCM) features in atypical melanocytic lesions scheduled for surgical excision, and to correlate these imaging features with molecular profiles obtained through Next-Generation Sequencing (NGS). Approximately 200 consecutive lesions, including atypical nevi and early-stage melanomas, will be analyzed from patients attending the Videomicroscopy and Confocal Clinic at the Dermatology Department of the University Hospital of Modena. The primary objective is to assess the diagnostic significance of RCM features-specifically atypical cells and disarrangement of the dermoepidermal junction (DEJ)-for early detection of melanoma. Secondary objectives include correlating RCM morphological patterns with NGS-derived genetic alterations and identifying molecular signatures that differentiate early-stage melanomas from benign nevi. All procedures are performed as part of routine clinical care, including dermoscopic and confocal evaluation, surgical excision, histopathology, and molecular analysis on formalin-fixed, paraffin-embedded blocks. Data will be anonymized, securely stored, and analyzed to determine associations between imaging and genetic variables. This study integrates morphological and molecular data to refine diagnostic workflows and improve early melanoma detection.

Key facts

Study ID

NCT07277920

Run by

University of Modena and Reggio Emilia

People needed

200

Starts

2023-11-01

Expected to finish

2026-12-31

Last updated by the study team

2025-12-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years
• Presence of cutaneous lesions with dermoscopic and reflectance confocal microscopy suspicion of melanocytic neoplasia, already scheduled for surgical excision
• Written informed consent obtained

You may not qualify if…

• Age < 18 years
• Lesions not scheduled for excision or with uncertain dermoscopic diagnosis
• Lack of informed consent

Where it is running

• Dermatology Department, University Hospital of Modena — Modena, Mo, Italy (enrolling)

Full record on ClinicalTrials.gov

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