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

NCT06908720 | Not Yet Recruiting

• 1 other identifier: CET 58-2025 (OSHMD)
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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

Conditions

Skin Cancers

Outcome Measures

Primary Outcomes (1)

• Evaluate the diagnostic accuracy and clinical utility of super-high magnification dermoscopy in the detection and differentiation of skin tumors

  Accuracy (sensibility and specificity) of dermoscopy 400x for detecting skin tumors (vs histopathological diagnosis)

  from the enrollment to the reaching of 1000 patients or up to 156 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who will come to our attention for skin cancer screening with dermoscopy, willing to partecipate to the study

You may qualify if:

• patients who will come to our attention for skin cancer screening with dermoscopy, willing to partecipate to the study

You may not qualify if:

• patients aged under 18 year old
• patients unable to understand and signed the onformed consent

Sponsors & Collaborators

• IRCCS Ospedale San Raffaele: lead

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Stefania Guida is a medical doctor, Specialist in Dermatology and Venereology, and holds a PhD in "Clinical and Experimental Medicine." She currently holds the position of researcher at the Clinical Dermatology Unit at HSR

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 3, 2025

Record last verified: 2025-04