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Skin imaging and gene testing of unusual moles and early melanoma

Compares skin imaging with gene testing in unusual moles and early melanomas.

Key facts

Who runs it
University of Modena and Reggio Emilia
Where
Modena, ItalySee the site
Trial code
Registry title
Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions
Status
Recruiting
People taking part
200 people, planned
Started
1 Nov 2023
Expected to end
31 Dec 2026
Type of study
Observational
Record updated
11 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a skin lesion that may be a melanocytic growth, such as an atypical mole or early melanoma, and that is already planned for surgical removal.

Age
18 years or older
Sex
All sexes can join
Disease stage
Skin lesions suspected to be melanocytic growths on dermoscopy and confocal microscopy, already scheduled for surgical excision

Main reasons for not taking part

  • Under 18 years old
  • Lesion not scheduled for removal
  • Uncertain dermoscopic diagnosis
  • No written informed consent

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Age < 18 years
  • Lesions not scheduled for excision or with uncertain dermoscopic diagnosis
  • Lack of informed consent

Where in Italy

  • Dermatology Department, University Hospital of ModenaModena, ItalyContact: Francesca FarnetaniTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluation of Reflectance Confocal Microscopy (RCM) Features in Surgically Excised Atypical Melanocytic Lesions and Their Correlation With Next-Generation Sequencing (NGS) Patterns
Plain-language title
Skin imaging and gene testing of unusual moles and early melanomaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
11 December 2025