Dermoscopy Augmented Histology Trial, a Randomized Controlled Trial

Sponsor
Herlev Hospital
Study ID
NCT05004792
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • DermLoop Learn — OTHER
    DermLoop Learn is a digital educational platform with case training on a library of 18,000+ benign and malignant skin lesions, educational material on the correlation between dermoscopy and histology, as well as written learning modules for the most common skin lesion diagnoses. The educational platform will give the user feedback on the image-based case training in dermoscopic diagnostic accuracy and adjust the cases depending on the user's progression.

Study Details

Pathologists provide the current gold standard in skin lesion diagnostics, most often primarily based on the interpretation of histological slides. Still, it has been suggested that pathologists' diagnostic accuracy and confidence could be improved if they gained access to additional clinical information and in-vivo clinical and dermoscopic images of melanocytic tumors. This study examines the effect of digital training for pathologists in interpreting dermoscopic and clinical skin tumor images. This study aims to evaluate the impact of dermoscopy training on pathologists' assessment of melanoma-suspected skin lesions. Data collection of DAHT cases: Department of plastic surgery, Herlev hospital, year 2020-2021, DAHT platform: Made in 2021-2023 by Melatech, Consensus agreement: Four dermatopathologists assess all DAHT cases, year 2023-2024 Enrollment of pathologists: Randomization and assessment DAHT cases, year 2026.

Key Dates

First listed
Aug 13, 2021
Start date
Aug 13, 2026
Status verified
Jun 2026
Primary completion
Dec 13, 2026
Completion
Dec 13, 2027

Study Design

Enrollment
258 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Intervention
    Access to DermLoop Learn IT platform
  • No Intervention: Control group
    No access to DermLoop Learn

Primary Outcome Measure

Expert Consensus Agreement MPATH-Dx Diagnosis Analysis: [ Time Frame: 6 months ]

Central Contacts

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