Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Modena and Reggio Emilia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Age < 18 years
Lesions not scheduled for excision or with uncertain dermoscopic diagnosis
Lack of informed consent
Trial population
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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 yearSecondary outcomes
1
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 yearOther outcomes
1
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Modena and Reggio Emilia
Lead sponsor
European Union
Collaborator
Source ClinicalTrials.gov