Defining the Role of Optical Super-high Magnification Dermoscopy in the Diagnosis of Skin Tumors

Not yet recruiting

• Conditions: Skin Cancers

• Registration Number: NCT06908720
• Lead Sponsor: IRCCS Ospedale San Raffaele

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted QC: 2025-04-02
• Last Update Submitted: 2025-04-02
• Study First Posted: 2025-04-03
• Last Update Posted: 2025-04-03
• Primary Completion: 2027-04
• Study Completion: 2027-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the diagnostic accuracy and clinical utility of super-high magnification dermoscopy in the detection and differentiation of skin tumors	from the enrollment to the reaching of 1000 patients or up to 156 weeks	Accuracy (sensibility and specificity) of dermoscopy 400x for detecting skin tumors (vs histopathological diagnosis)