Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanocytic Nevi | Pigmented Nevus | ALIAS | 0.90 |
| Melanoma (Skin Cancer) | Melanoma | ONTOLOGY_EXACT | 0.85 |
| Next Generation Sequencing (NGS) | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic relevance of RCM features in atypical melanocytic lesions
- timeFrame
- through study completion, an average of 1 year
- description
- Evaluation of the presence of atypical cells (\>20 µm, dendritic or round, suprabasal or at the dermoepidermal junction level) and disarrangement of the dermoepidermal junction (non-edged papillae, chaotic patterns, architectural irregularity) using Reflectance Confocal Microscopy (RCM), and comparison with histopathological diagnosis.
Secondary outcomes (1)
- measure
- Differential gene expression profiles distinguishing nevi and early-stage melanomas
- timeFrame
- through study completion, an average of 1 year
- description
- Quantitative assessment of molecular features obtained through genomic/molecular analysis to identify patterns that distinguish benign nevi from early-stage melanomas. Data will be summarized as differential expression levels and/or frequency of molecular alterations.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDMesbah Ardakani N. Dysplastic/Clark naevus in the era of molecular pathology. Australas J Dermatol. 2019 Aug;60(3):186-191. doi: 10.1111/ajd.13019. Epub 2019 Mar 10. PMID 30854639
- BACKGROUNDPiepkorn MW, Barnhill RL, Elder DE, Knezevich SR, Carney PA, Reisch LM, Elmore JG. The MPATH-Dx reporting schema for melanocytic proliferations and melanoma. J Am Acad Dermatol. 2014 Jan;70(1):131-41. doi: 10.1016/j.jaad.2013.07.027. Epub 2013 Oct 28. PMID 24176521
- BACKGROUNDFerrara G, Argenziano G, Soyer HP, Corona R, Sera F, Brunetti B, Cerroni L, Chimenti S, El Shabrawi-Caelen L, Ferrari A, Hofmann-Wellenhof R, Kaddu S, Piccolo D, Scalvenzi M, Staibano S, Wolf IH, De Rosa G. Dermoscopic and histopathologic diagnosis of equivocal melanocytic skin lesions: an interdisciplinary study on 107 cases. Cancer. 2002 Sep 1;95(5):1094-100. doi: 10.1002/cncr.10768. PMID 12209696
- BACKGROUNDKozubek J, Ma Z, Fleming E, Duggan T, Wu R, Shin DG, Dadras SS. In-depth characterization of microRNA transcriptome in melanoma. PLoS One. 2013 Sep 4;8(9):e72699. doi: 10.1371/journal.pone.0072699. eCollection 2013. PMID 24023765
- BACKGROUNDSadrolashrafi K, Cotter DG. Not Your Mother's Melanoma: Causes and Effects of Early Melanoma Diagnosis. Dermatopathology (Basel). 2022 Nov 27;9(4):368-378. doi: 10.3390/dermatopathology9040043. PMID 36547217
- BACKGROUNDNavarrete-Dechent C, DeRosa AP, Longo C, Liopyris K, Oliviero M, Rabinovitz H, Marghoob AA, Halpern AC, Pellacani G, Scope A, Jain M. Reflectance confocal microscopy terminology glossary for nonmelanocytic skin lesions: A systematic review. J Am Acad Dermatol. 2019 May;80(5):1414-1427.e3. doi: 10.1016/j.jaad.2018.12.007. Epub 2018 Dec 8. PMID 30529706
- BACKGROUNDPellacani G, Farnetani F, Gonzalez S, Longo C, Cesinaro AM, Casari A, Beretti F, Seidenari S, Gill M. In vivo confocal microscopy for detection and grading of dysplastic nevi: a pilot study. J Am Acad Dermatol. 2012 Mar;66(3):e109-21. doi: 10.1016/j.jaad.2011.05.017. Epub 2011 Jul 13.