Clinical trial · Observational
Defining the Role of Optical Super-high Magnification Dermoscopy in the Diagnosis of Skin Tumors
A Prospective Observational Study for Defining the Role of Optical Super-high Magnification Dermoscopy in the Diagnosis of Skin Tumors
- 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 is a prospective study aimed at evaluating the diagnostic accuracy (compared to histopathological diagnosis) and clinical utility of optical super-high magnification dermoscopy (OSHMD) in detecting and differentiating skin tumors, including both benign and malignant lesions, particularly in nevi/melanoma and basal cell carcinoma, in patients with suspicious lesions at a magnification of 20x. Additionally, the characteristics of skin lesions will be analyzed using OSHMD, and their distribution in skin tumors will be assessed. The agreement between the examiners' evaluations and the concordance between dermoscopic diagnoses at 20x and 400x compared to histopathological diagnosis will also be examined. The hypothesis is that OSHMD could assist in identifying malignancy features, thus improving the diagnostic accuracy of skin tumors and potentially leading to earlier and more precise detection of neoplasms
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 |
|---|---|---|---|
| Skin Cancers | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the diagnostic accuracy and clinical utility of super-high magnification dermoscopy in the detection and differentiation of skin tumors
- timeFrame
- from the enrollment to the reaching of 1000 patients or up to 156 weeks
- description
- Accuracy (sensibility and specificity) of dermoscopy 400x for detecting skin tumors (vs histopathological diagnosis)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * patients who will come to our attention for skin cancer screening with dermoscopy, willing to partecipate to the study Exclusion Criteria: * patients aged under 18 year old * patients unable to understand and signed the onformed consent
References
Publications (0)
Data not yet available