Dermoscopy Augmented Histology Trial, a Randomized Controlled Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorHerlev Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Pathologists are required to evaluate melanocytic lesions routinely
Doctors must be registered authorized health personnel
Access to a smartphone/tablet/computer with internet
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
DermLoop Learn
Other interventionDermLoop 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.
Treatment groups
258 Participants
are divided into 2 treatment groupsGroup A: InterventionActive comparator 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Expert Consensus Agreement MPATH-Dx Diagnosis Analysis:
Assessing the pathologists' ability to correctly identify the exact diagnosis compared to a gold standard established by a consensus panel of four expert pathologists.
Time frame
6 months2
Expert Consensus Agreement MPATH-Dx Class Analysis:
Evaluating the pathologists' ability to classify lesions using the MPATH-Dx 2.0 framework, which categorizes lesions into one of four diagnostic classes.
Time frame
6 monthsSecondary outcomes
1
Inter-rater reliability
comparison of diagnosis between participants
Time frame
6 months2
training time vs time spent/DAHT case
Correlation between time spent training and time spent diagnosing DAHT cases.
Time frame
1 month3
Use of clinical information
analysis of the use of clinical information for each case. Comparison of groups
Time frame
6 months4
Use of clinical and/or dermoscopic images
If participants click on the clinical and/or dermoscopic images as a part of their assessment
Time frame
6 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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