NCT07277920Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 19 Nov 2025
- Start date
- 1 Nov 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- University of Modena and Reggio Emilia
- Diseases
- Melanoma
- NCT number
- NCT07277920
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Nov 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Age
- Age \< 18 years
Other
- Lesions not scheduled for excision or with uncertain dermoscopic diagnosis
- Lack of informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dermatology Department, University Hospital of Modena Coordinator of this site? Confirm its status | Modena | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.