Confocal imaging and genetic testing of atypical moles and early melanoma
Official title: Evaluation of Reflectance Confocal Microscopy (RCM) Features in Surgically Excised Atypical Melanocytic Lesions and Their Correlation With Next-Generation Sequencing (NGS) Patterns
Run by University of Modena and Reggio Emilia · NCT07277920 · Data updated 2026-11-12
This project will try to see if noninvasive confocal images of suspicious moles match genetic changes from sequencing in adults who are having the lesions removed.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Modena and Reggio Emilia Academic / other |
| Locations | 1 site (Modena, Mo) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | December 11, 2025 |
| Trial ID | NCT07277920 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (age 18 or older) with melanocytic skin lesions that are dermoscopically suspicious and already scheduled for surgical excision, who can give informed consent.
✕Probably not a fit
People without a lesion scheduled for excision, children under 18, or patients whose lesions are clearly benign on standard exams are unlikely to benefit from this project.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective observational cohort will enroll about 200 atypical nevi and early melanomas scheduled for surgical excision at the University Hospital of Modena. Each lesion will undergo reflectance confocal microscopy (RCM) before removal, and excised tissue will receive next-generation sequencing (NGS) to profile genetic alterations. Researchers will correlate RCM features such as atypical cells and dermoepidermal junction disarray with molecular findings to identify patterns that distinguish early melanoma from benign nevi. No experimental treatments are given; imaging and molecular analyses are performed alongside routine clinical care.
Why it matters
Potential benefit: If successful, this could help doctors spot early melanomas more accurately and avoid unnecessary removals by linking imaging patterns to genetic risk markers.
How similar studies have gone: RCM has been shown to reduce unnecessary excisions and NGS reliably identifies mutations, but directly correlating RCM features with lesion-level NGS profiles in a prospective cohort is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Dermatology Department, University Hospital of Modena
Modena, Mo, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.