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Not yet recruitingNCT06908720OSHMDUpdated Apr 3, 2025

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

An observational study in Skin Cancers, sponsored by IRCCS Ospedale San Raffaele. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-03.

Sponsored by IRCCS Ospedale San Raffaele · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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

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Conditions studied

  • Skin Cancers

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In context

Skin Neoplasms

582 studies on the registry are indexed under Skin Neoplasms; 114 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 200 across 134 observational studies indexed under Skin Neoplasms.

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Lead sponsor

IRCCS Ospedale San Raffaele is the lead sponsor of 34 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes
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What researchers measure

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)

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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06908720
Lead sponsor
IRCCS Ospedale San Raffaele
Responsible party
Guida Stefania (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, IRCCS Ospedale San Raffaele) — Principal investigator
First posted
Apr 3, 2025
Start date
Apr 2025 (estimated)
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Apr 3, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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