Melanocytic NeviNCT07277920
Reflectance Confocal Microscopy and Molecular Correlation in Atypical Melanocytic Lesions
An observational study of Melanocytic Nevi and Melanoma (Skin Cancer), run by University of Modena and Reggio Emilia at 1 site in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanocytic Nevi, Melanoma (Skin Cancer), Next Generation Sequencing (NGS)
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Approximately 200 melanocytic lesions from adult patients (age ≥18 years) scheduled for surgical excision due to dermoscopic suspicion of atypical nevus or early-stage melanoma will be included. Patients of all genders are eligible. Lesions will be evaluated using routine clinical assessment, dermoscopy, and Reflectance Confocal Microscopy (RCM). Histopathological evaluation will be performed on all excised lesions. Molecular analysis via Next-Generation Sequencing (NGS) will be performed on lesions with available tissue, and not all lesions may undergo NGS. Participants are recruited consecutively at the Videomicroscopy and Confocal Clinic, Dermatology Department, University Hospital of Modena.
Who may be able to join
- 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
Who cannot join
- Age < 18 years
- Lesions not scheduled for excision or with uncertain dermoscopic diagnosis
- Lack of informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Dermatology Department, University Hospital of Modena
Modena, Mo, 41125
Francesca Farnetani, 0039 0594222347, francesca.farnetani@unimore.it
About this study
Official title: Evaluation of Reflectance Confocal Microscopy (RCM) Features in Surgically Excised Atypical Melanocytic Lesions and Their Correlation With Next-Generation Sequencing (NGS) Patterns
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.
Read the detailed description
Background and Rationale
Reflectance confocal microscopy (RCM) is a non-invasive imaging technique that allows in vivo evaluation of the skin with near-histologic resolution. Integrating RCM into clinical dermatology has been shown to reduce unnecessary excisions of benign lesions and improve diagnostic accuracy compared with dermoscopy alone.
Next-Generation Sequencing (NGS) enables the identification of key genetic mutations in atypical nevi and melanomas, providing valuable insights into their biological behavior and potential malignant transformation.
This study aims to evaluate the correlation between characteristic RCM features and molecular findings obtained through NGS in melanocytic lesions already scheduled for surgical excision, to improve early diagnosis of melanoma and risk classification.
Objectives Primary Objective
To assess the diagnostic relevance of characteristic RCM features - specifically atypical cells and DEJ disarrangement - in melanocytic lesions already scheduled for surgical excision due to dermoscopic suspicion of atypical nevus or melanoma.
Secondary Objectives
To correlate RCM morphological features with molecular profiles obtained through NGS in both nevi and early-stage melanomas, comparing the genetic and morphologic patterns between these two groups.
To identify distinctive biological and molecular signatures that may differentiate early-stage melanomas from benign nevi, providing potential markers for early diagnosis and risk stratification.
Funding Statement
This study is funded by the European Union - NextGenerationEU, through the Italian Ministry of University and Research (MUR) under PNRR - M4C2-I1.3 Project PE_00000019 HEAL ITALIA, CUP E93C22001860006.
- Medical subject headings
- Nevus, Pigmented, Melanoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic relevance of RCM features in atypical melanocytic lesions
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.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
Differential gene expression profiles distinguishing nevi and early-stage melanomas
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Nov 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Melanocytic NeviStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Modena and Reggio Emilia
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Principal investigator, Francesca Farnetani, University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277920
- Sponsor's protocol ID
- UNIMORE-DERM-2025-01
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 11 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mesbah 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.
PubMed 30854639Piepkorn 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.
PubMed 24176521Ferrara 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.
PubMed 12209696Kozubek 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.
PubMed 24023765Sadrolashrafi 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.
PubMed 36547217Navarrete-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.
PubMed 30529706Pellacani 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.
PubMed 21742408Argenziano G, Catricala C, Ardigo M, Buccini P, De Simone P, Eibenschutz L, Ferrari A, Mariani G, Silipo V, Sperduti I, Zalaudek I. Seven-point checklist of dermoscopy revisited. Br J Dermatol. 2011 Apr;164(4):785-90. doi: 10.1111/j.1365-2133.2010.10194.x. Epub 2011 Mar 10.
PubMed 21175563Alma A, Beretti F, Bonilauri C, Chester J, Kaleci S, Ciardo S, Bertoni L, Pellacani G, Farnetani F. Atypical naevi in dermoscopy and reflectance confocal microscopy: correlation between immunohistochemistry and diagnostic patterns of atypia. Clin Exp Dermatol. 2024 Dec 23;50(1):172-174. doi: 10.1093/ced/llae326. No abstract available.
PubMed 39180293Gandini S, Sera F, Cattaruzza MS, Pasquini P, Abeni D, Boyle P, Melchi CF. Meta-analysis of risk factors for cutaneous melanoma: I. Common and atypical naevi. Eur J Cancer. 2005 Jan;41(1):28-44. doi: 10.1016/j.ejca.2004.10.015.
PubMed 15617989
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Reflectance Confocal Microscopy (RCM) Features in Surgically Excised Atypical Melanocytic Lesions and Their Correlation With Next-Generation Sequencing (NGS) Patterns
- ClinicalTrials.gov ID
- NCT07277920
- Acronym / sponsor ID
- UNIMORE-DERM-2025-01
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of Modena and Reggio EmiliaUniversity, hospital or other
- Collaborators
- European Union
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale
Reflectance confocal microscopy (RCM) is a non-invasive imaging technique that allows in vivo evaluation of the skin with near-histologic resolution. Integrating RCM into clinical dermatology has been shown to reduce unnecessary excisions of benign lesions and improve diagnostic accuracy compared with dermoscopy alone.
Next-Generation Sequencing (NGS) enables the identification of key genetic mutations in atypical nevi and melanomas, providing valuable insights into their biological behavior and potential malignant transformation.
This study aims to evaluate the correlation between characteristic RCM features and molecular findings obtained through NGS in melanocytic lesions already scheduled for surgical excision, to improve early diagnosis of melanoma and risk classification.
Objectives Primary Objective
To assess the diagnostic relevance of characteristic RCM features - specifically atypical cells and DEJ disarrangement - in melanocytic lesions already scheduled for surgical excision due to dermoscopic suspicion of atypical nevus or melanoma.
Secondary Objectives
To correlate RCM morphological features with molecular profiles obtained through NGS in both nevi and early-stage melanomas, comparing the genetic and morphologic patterns between these two groups.
To identify distinctive biological and molecular signatures that may differentiate early-stage melanomas from benign nevi, providing potential markers for early diagnosis and risk stratification.
Funding Statement
This study is funded by the European Union - NextGenerationEU, through the Italian Ministry of University and Research (MUR) under PNRR - M4C2-I1.3 Project PE_00000019 HEAL ITALIA, CUP E93C22001860006.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Approximately 200 melanocytic lesions from adult patients (age ≥18 years) scheduled for surgical excision due to dermoscopic suspicion of atypical nevus or early-stage melanoma will be included. Patients of all genders are eligible. Lesions will be evaluated using routine clinical assessment, dermoscopy, and Reflectance Confocal Microscopy (RCM). Histopathological evaluation will be performed on all excised lesions. Molecular analysis via Next-Generation Sequencing (NGS) will be performed on lesions with available tissue, and not all lesions may undergo NGS. Participants are recruited consecutively at the Videomicroscopy and Confocal Clinic, Dermatology Department, University Hospital of Modena.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Age < 18 years
- Lesions not scheduled for excision or with uncertain dermoscopic diagnosis
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic relevance of RCM features in atypical melanocytic lesions
Time frame: through study completion, an average of 1 year
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.
1 secondary outcome
Differential gene expression profiles distinguishing nevi and early-stage melanomas
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Background: PubMed 30854639Mesbah 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.
- Background: PubMed 24176521Piepkorn 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.
- Background: PubMed 12209696Ferrara 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.
- Background: PubMed 24023765Kozubek 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.
- Background: PubMed 36547217Sadrolashrafi 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.
- Background: PubMed 30529706Navarrete-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.
- Background: PubMed 21742408Pellacani 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.
- Background: PubMed 21175563Argenziano G, Catricala C, Ardigo M, Buccini P, De Simone P, Eibenschutz L, Ferrari A, Mariani G, Silipo V, Sperduti I, Zalaudek I. Seven-point checklist of dermoscopy revisited. Br J Dermatol. 2011 Apr;164(4):785-90. doi: 10.1111/j.1365-2133.2010.10194.x. Epub 2011 Mar 10.
- Background: PubMed 39180293Alma A, Beretti F, Bonilauri C, Chester J, Kaleci S, Ciardo S, Bertoni L, Pellacani G, Farnetani F. Atypical naevi in dermoscopy and reflectance confocal microscopy: correlation between immunohistochemistry and diagnostic patterns of atypia. Clin Exp Dermatol. 2024 Dec 23;50(1):172-174. doi: 10.1093/ced/llae326. No abstract available.
- Background: PubMed 15617989Gandini S, Sera F, Cattaruzza MS, Pasquini P, Abeni D, Boyle P, Melchi CF. Meta-analysis of risk factors for cutaneous melanoma: I. Common and atypical naevi. Eur J Cancer. 2005 Jan;41(1):28-44. doi: 10.1016/j.ejca.2004.10.015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dermatology Department, University Hospital of Modena
Modena, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanocytic Nevi and Melanoma (Skin Cancer), run by University of Modena and Reggio Emilia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic relevance of RCM features in atypical melanocytic lesions (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07277920, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.