NCT07277920 Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions
| NCT ID | NCT07277920 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Modena and Reggio Emilia |
| Condition | Melanocytic Nevi |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2023-11-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Age \< 18 years * Lesions not scheduled for excision or with uncertain dermoscopic diagnosis * Lack of informed consent
Frequently Asked Questions
Who can join the NCT07277920 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melanocytic Nevi. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07277920 currently recruiting?
Yes, NCT07277920 is actively recruiting participants. Visit ClinicalTrials.gov or contact University of Modena and Reggio Emilia to inquire about joining.
Where is the NCT07277920 trial being conducted?
This trial is being conducted at Modena, Italy.
Who is sponsoring the NCT07277920 clinical trial?
NCT07277920 is sponsored by University of Modena and Reggio Emilia. The trial plans to enroll 200 participants.