RecruitingNCT07277920

Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions

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


Sponsor

University of Modena and Reggio Emilia

Enrollment

200 participants

Start Date

Nov 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is examining suspicious moles and other skin lesions using a non-invasive imaging technique called reflectance confocal microscopy (like a microscope that sees skin layers without cutting) and then comparing the images to molecular lab results after the lesion is surgically removed. **You may be eligible if...** - You are 18 or older - You have a suspicious mole or pigmented skin lesion that a skin specialist has recommended for surgical removal - You have given written consent **You may NOT be eligible if...** - You are under 18 - Your lesion is not already scheduled for removal or has an uncertain diagnosis - You have not provided informed consent Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.


Locations(1)

Dermatology Department, University Hospital of Modena

Modena, Mo, Italy

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NCT07277920


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