Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions

NCT ID: NCT07277920

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-11-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Detailed Description

Background and Rationale

Reflectance confocal microscopy (RCM) is a non-invasive imaging technique that allows in vivo evaluation of the skin with near-histologic resolution. Integrating RCM into clinical dermatology has been shown to reduce unnecessary excisions of benign lesions and improve diagnostic accuracy compared with dermoscopy alone.

Next-Generation Sequencing (NGS) enables the identification of key genetic mutations in atypical nevi and melanomas, providing valuable insights into their biological behavior and potential malignant transformation.

This study aims to evaluate the correlation between characteristic RCM features and molecular findings obtained through NGS in melanocytic lesions already scheduled for surgical excision, to improve early diagnosis of melanoma and risk classification.

Objectives Primary Objective

To assess the diagnostic relevance of characteristic RCM features - specifically atypical cells and DEJ disarrangement - in melanocytic lesions already scheduled for surgical excision due to dermoscopic suspicion of atypical nevus or melanoma.

Secondary Objectives

To correlate RCM morphological features with molecular profiles obtained through NGS in both nevi and early-stage melanomas, comparing the genetic and morphologic patterns between these two groups.

To identify distinctive biological and molecular signatures that may differentiate early-stage melanomas from benign nevi, providing potential markers for early diagnosis and risk stratification.

Funding Statement

This study is funded by the European Union - NextGenerationEU, through the Italian Ministry of University and Research (MUR) under PNRR - M4C2-I1.3 Project PE_00000019 HEAL ITALIA, CUP E93C22001860006.

Conditions

Melanocytic Nevi; Melanoma (Skin Cancer); Next Generation Sequencing (NGS)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Union

OTHER

Sponsor Role: collaborator

University of Modena and Reggio Emilia

OTHER

Sponsor Role: lead

Responsible Party

Francesca Farnetani

Professor / PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dermatology Department, University Hospital of Modena

Modena, Mo, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Francesca Farnetani

Role: primary

francesca.farnetani@unimore.it

0039 0594222347

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Other Identifiers

UNIMORE-DERM-2025-01

Identifier Type: -

Identifier Source: org_study_id