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NCT07277920

Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions

Recruiting now Last updated 11 December 2025
What this trial tests

trial in Melanocytic Nevi in 200 participants. Currently enrolling.

Timeline
1 November 2023
Primary endpoint
31 December 2025
31 December 2026

Quick facts

Lead sponsorUniversity of Modena and Reggio Emilia
StatusRecruiting now
Study typeOBSERVATIONAL
Enrollment200
Start date1 November 2023
Primary completion31 December 2025
Estimated completion31 December 2026
Sites1 location across Italy

Conditions studied

Sponsor

University of Modena and Reggio Emilia

Who can join

18 and older, any sex, with Melanocytic Nevi or Melanoma (Skin Cancer). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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