Clinical trial · Interventional
Advanced Non-invasive Diagnostics for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic and Economic Management
Multicenter, Randomised Study of the Impact of Advanced, Non-invasive Diagnostic Instrumentation for Early Cutaneous Tumor Diagnosis, Clinical-therapeutic Pathways and an Economic-management Perspective
- 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)
The incidence of cutaneous melanoma (MM) is increasing worldwide. The best therapeutical solution for MM is early diagnosis and efforts over the last 50 years have been directed towards early and precise diagnoses. Dermoscopy has improved diagnostic accuracy compared to the naked eye, but is limited by an associated higher number of unnecessary excisions. Reflectance confocal microscopy (RCM) is a novel technique enabling in vivo examination of the skin at cellular-level resolution, with excellent diagnostic accuracy. This study hypothesis is that the systematic application of RCM in the triage and management of patients suspicious for skin cancer, may improve diagnostic accuracy and reduce the number of unnecessary biopsy. Reducing the burden of unnecessary surgery excisions should benefit the health system, both in saving surgical and pathology procedural associated costs and reducing the overwhelming waiting lists for excisions and consequent risk for delayed diagnoses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clinical, dermoscopy and Reflective confocal microscopy evaluations | Device | — | UNRESOLVED |
| Clinical, dermoscopy evaluations | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm 1 (interventional)
- description
- Patients with equivocal skin lesions suspicious for melanoma, randomised to adjunctive RCM evaluation, following clinical and dermoscopy evaluation.
- interventionNames
- Device: Clinical, dermoscopy and Reflective confocal microscopy evaluations
- type
- PLACEBO_COMPARATOR
- label
- Arm 2 (control)
- description
- Patients with equivocal skin lesions suspicious for melanoma, randomised to clinical and dermoscopy evaluation only; adjunctive RCM evaluation refused.
- interventionNames
- Device: Clinical, dermoscopy evaluations
Primary outcomes (3)
- measure
- Number needed to excise (NNE)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- Patient's with at least 1 unequivocal lesion following standard of care (clinical and dermoscopy evaluations), \>= 18 years old Exclusion Criteria: * (i) the presence of an unequivocal aspect of melanoma or of any other malignant skin cancer, * (ii) lesion located on a skin area where reflectance confocal microscopy cannot be performed (for example: skin folds, mucosa, etc.), * (iii) lesion larger than 2 cm in its largest diameter * (iv) lesion where RCM examination is hampered for over the 30% of its surface (for example, for presence of crusting, oozing, erosion, ulceration, etc.).
References
Publications (3)
- DERIVEDGuida S, Spadafora M, Ciardo S, Mirra M, Magi S, Mazzoni L, Kaleci S, Farnetani F, Rongioletti F, Stanganelli I, Pellacani G, Longo C. Improving basal cell carcinoma subtype diagnosis with dermoscopy and reflectance confocal microscopy: a multicentre prospective study. Clin Exp Dermatol. 2026 Jun 25;51(7):1247-1254. doi: 10.1093/ced/llag037. PMID 41685950
- DERIVEDLongo C, Guida S, Mirra M, Pampena R, Ciardo S, Bassoli S, Casari A, Rongioletti F, Spadafora M, Chester J, Kaleci S, Lai M, Magi S, Mazzoni L, Farnetani F, Stanganelli I, Pellacani G. Dermatoscopy and reflectance confocal microscopy for basal cell carcinoma diagnosis and diagnosis prediction score: A prospective and multicenter study on 1005 lesions. J Am Acad Dermatol. 2024 May;90(5):994-1001. doi: 10.1016/j.jaad.2024.01.035. Epub 2024 Jan 30. PMID 38296197
- DERIVEDPellacani G, Farnetani F, Ciardo S, Chester J, Kaleci S, Mazzoni L, Bassoli S, Casari A, Pampena R, Mirra M, Lai M, Magi S, Mandel VD, Di Matteo S, Colombo GL, Stanganelli I, Longo C. Effect of Reflectance Confocal Microscopy for Suspect Lesions on Diagnostic Accuracy in Melanoma: A Randomized Clinical Trial. JAMA Dermatol. 2022 Jul 1;158(7):754-761. doi: 10.1001/jamadermatol.2022.1570. PMID 35648432