Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Melanoma (Skin Cancer) trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment200 (estimated)
SponsorUniversity of Modena and Reggio Emilia
Academic / other
Locations1 site (Modena, Mo)
StatusRecruiting
StartedNovember 1, 2023
Main results expectedDecember 31, 2025
Study endsDecember 31, 2026
Registry record updatedDecember 11, 2025
Trial IDNCT07277920 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.