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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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06908720
Acronym
OSHMD
Enrollment
1000
Registered
2025-04-03
Start date
2025-04-30
Completion date
2027-04-30
Last updated
2025-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Cancers

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

Interventions

None listed

Sponsors

IRCCS Ospedale San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the diagnostic accuracy and clinical utility of super-high magnification dermoscopy in the detection and differentiation of skin tumorsfrom the enrollment to the reaching of 1000 patients or up to 156 weeksAccuracy (sensibility and specificity) of dermoscopy 400x for detecting skin tumors (vs histopathological diagnosis)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026