Actively Recruiting

Age: 18Years +
All Genders
NCT07277920

Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions

Led by University of Modena and Reggio Emilia · Updated on 2025-12-11

200

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

U

University of Modena and Reggio Emilia

Lead Sponsor

E

European Union

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Presence of skin lesions suspected of melanocytic neoplasia by dermoscopy and reflectance confocal microscopy, scheduled for surgical removal
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Skin lesions not scheduled for surgical removal or with uncertain dermoscopic diagnosis
  • Lack of written informed consent

AI-Screening

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Trial Site Locations

Total: 1 location

1

Dermatology Department, University Hospital of Modena

Modena, Mo, Italy, 41125

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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