AI Augmented Training for Skin Specialists

NCT04758988 | Completed

• 1 other identifier: AISC-SS
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 2

Brief Summary

Background: The worldwide incidence of skin cancer has been rising for 50 years, in particular the incidence of malignant melanoma has increased approx. 2-7% annually and is the most common cancer amongst Danes aged 15-34. Currently there is a significant amount of misdiagnosis of skin cancer and mole cancer, and most excised skin lesions are benign. Previous studies have shown that there is no significant increase in doctors diagnostic accuracy during the first 6 years of clinical work. The resources spend on healthy people could be put to better use, if the Benign-Malignant Ratio could be lowered. This could potentially be done by better educating the doctors during their everyday clinical practice. Aim: The aim of this study is to investigate the dose/response effect of an AI augmented training and clinical feedback on the diagnostic accuracy of skin cancer and clinical decisions among doctors from specialized skin cancer centers. Research question: How much specialized doctors need to train before their diagnostic accuracy and clinical decisions change?

Conditions

Melanoma; Skin Cancer

Keywords

Artificial Intelligence; Education; Diagnostic Accuracy; Skin Cancer; Melanoma; Feedback loop

Outcome Measures

Primary Outcomes (1)

• Dose/Response

  Dose/response between hours spent with the education system and change in diagnostic accuracy for the participating doctors

  2 years

Secondary Outcomes (3)

• BMR

  2 years

• Multiple-Choice-Questionnaire predictability of diagnostic accuracy

  2 months

• Referrals

  2 years

Study Arms (2)

Group A

OTHER

This group will receive access to the AI augmented digital online educational system and its two modules (Training Module and Clinical Feedback Module). They will receive continuous clinical feedback on their registered lesions.

Other: DermLoop Learn

Group B

NO INTERVENTION

This group is withheld their access to the AI augmented digital online educational system for 2 months. After the 2 months delay, the subjects in the group are given the same access as the participants in Group A.

Interventions

DermLoop Learn OTHER

DermLoop Learn is our AI augmented digital online educational system with case training on a library of 10,000+ benign and malignant skin lesion as well as written learning modules for the most common skin lesion diagnosis.

Group A

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Doctors are required to work at a specialized skin department (dermatology or plastic surgery or the like).
• Doctors must be registered authorized health personnel

You may not qualify if:

• Doctors that have previously received access to the DermLoop Learn educational intervention
• Doctors with less than 2 months left of their affiliation with their current department of employment

Sponsors & Collaborators

• Herlev Hospital: lead

Study Sites (2)

Herlev Hospital

Copenhagen, 2730, Denmark

Location

Gentofte Hospital

Copenhagen, 2900, Denmark

Location

MeSH Terms

Conditions

Melanoma; Skin Neoplasms

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Gustav G Nervil, MD

  Herlev Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participating doctors are either given access to an AI augmented digital educational online system or not. During the study period, doctors of both groups are registering skin lesions they encounter in their daily practice using the same hardware and software. The expert dermatologists that evaluate the registered skin lesions are unaware of the registering doctors allocation.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A randomized superiority clinical trial. Participating doctors are randomized to either group A or B in a 1:1 ratio.

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 17, 2021
• Study Start: September 15, 2021
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Locations

DK (2)