Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07277920

Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Melanocytic Nevi Melanoma Melanoma (Skin Cancer) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus Nevus, Pigmented Next Generation Sequencing (NGS) Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dermatology Department, University Hospital of Modena

Modena, Mo, 41125, Italy

Location status: Recruiting

Location contact

Francesca Farnetani

CONTACT

[email protected]

0039 0594222347

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Diagnostic relevance of RCM features in atypical melanocytic lesions

    Time frame: through study completion, an average of 1 year

    Evaluation of the presence of atypical cells (>20 µm, dendritic or round, suprabasal or at the dermoepidermal junction level) and disarrangement of the dermoepidermal junction (non-edged papillae, chaotic patterns, architectural irregularity) using Reflectance Confocal Microscopy (RCM), and comparison with histopathological diagnosis.

Secondary outcomes

  1. Differential gene expression profiles distinguishing nevi and early-stage melanomas

    Time frame: through study completion, an average of 1 year

    Quantitative assessment of molecular features obtained through genomic/molecular analysis to identify patterns that distinguish benign nevi from early-stage melanomas. Data will be summarized as differential expression levels and/or frequency of molecular alterations.

Other outcomes

  1. Correlation between RCM morphological patterns and NGS-derived molecular signatures

    Time frame: through study completion, an average of 1 year

    Outcome Measure Description

    Quantitative correlation analysis between:

    RCM morphological features, measured using Reflectance Confocal Microscopy (RCM) (e.g., presence of atypical cells, dermoepidermal junction disarrangement, architectural irregularity), summarized as categorical imaging features, and

    NGS-derived molecular signatures, measured through Next-Generation Sequencing (NGS), including identification of specific genes showing differential expression or genomic alterations, not only presence/absence of alterations.

    The reported outcome will be the correlation coefficient between imaging-defined RCM patterns and gene-level molecular profiles identified through NGS.

    Unit of Measure:

    Correlation coefficient (r value)

    Measurement Tools:

    Reflectance Confocal Microscopy (RCM) for morphological features

    Next-Generation Sequencing (NGS) for molecular signatures

Sponsors and collaborators

Lead sponsor

University of Modena and Reggio Emilia

Other

Collaborators

  • European Union

Registry information

Official study title

Evaluation of Reflectance Confocal Microscopy (RCM) Features in Surgically Excised Atypical Melanocytic Lesions and Their Correlation With Next-Generation Sequencing (NGS) Patterns

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Dec 11, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.