Confocal imaging and genetic testing of atypical moles and early melanoma
Evaluation of Reflectance Confocal Microscopy (RCM) Features in Surgically Excised Atypical Melanocytic Lesions and Their Correlation With Next-Generation Sequencing (NGS) Patterns
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Modena and Reggio Emilia Academic / other |
| Locations | 1 site (Modena, Mo) |
| Trial ID | NCT07277920 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Modena, Mo
- Dermatology Department, University Hospital of Modena — Modena, Mo, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.