An observational study in Melanocytic Nevi, Melanoma (Skin Cancer) and Next Generation Sequencing (NGS), sponsored by University of Modena and Reggio Emilia. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-11.
Sponsored by University of Modena and Reggio Emilia · Observational
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.
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.
19 studies on the registry are indexed under Nevus, Pigmented; 6 are open to participants now.
This study's planned enrollment of 200 is above the median of 50 across 11 observational studies indexed under Nevus, Pigmented.
Browse Nevus, Pigmented studies →University of Modena and Reggio Emilia is the lead sponsor of 65 studies on the registry; 17 are open to participants now.
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Approximately 200 melanocytic lesions from adult patients (age ≥18 years) scheduled for surgical excision due to dermoscopic suspicion of atypical nevus or early-stage melanoma will be included. Patients of all genders are eligible. Lesions will be evaluated using routine clinical assessment, dermoscopy, and Reflectance Confocal Microscopy (RCM). Histopathological evaluation will be performed on all excised lesions. Molecular analysis via Next-Generation Sequencing (NGS) will be performed on lesions with available tissue, and not all lesions may undergo NGS. Participants are recruited consecutively at the Videomicroscopy and Confocal Clinic, Dermatology Department, University Hospital of Modena.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic relevance of RCM features in atypical melanocytic lesions
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.
Time frame: through study completion, an average of 1 year
Differential gene expression profiles distinguishing nevi and early-stage melanomas
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.
Time frame: through study completion, an average of 1 year
Correlation between RCM morphological patterns and NGS-derived molecular signatures
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
Time frame: through study completion, an average of 1 year
Started Nov 2023 (actual). Primary completion is estimated for Dec 2025, 25 months after the start.
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University of Modena and Reggio Emilia