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NCT04576416: AISC-GP
Artificial Intelligence Augmented Training in Skin Cancer Diagnostics for General Practitioners
NA trial testing AI augmented training and clinical feedback in Melanoma in 115 participants. Completed in 31 January 2022.
15 January 2022
Quick facts
| Lead sponsor | Herlev Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 115 |
| Start date | 1 November 2021 |
| Primary completion | 15 January 2022 |
| Estimated completion | 31 January 2022 |
| Sites | 1 location across Denmark |
Drugs / interventions tested
- AI augmented training and clinical feedback
Conditions studied
- Melanoma — all drugs for Melanoma →
- Skin Cancer — all drugs for Skin Cancer →
Sponsor
Herlev Hospital
Who can join
Eligibility, any sex, with Melanoma or Skin Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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. Our aim is to improve general practitioners' diagnostic skills and accuracy of skin and mole cancer. Research questions: In a population of Danish General Practitioners (GPs) what is the dose/response effect of hours spent with an educational platform that offers AI augmented training and clinical feedback on their diagnostic accuracy and accurate clinical management (treatment, dismissal, referral)? Does access to an educational platform that offers AI augmented training and clinical feedback increase the number of malignant skin lesions referred by Danish GPs without simultaneously increasing the number of incorrect benign referrals? Can the participating GPs clinical accuracy be predicted from the MCQ-score by comparing their quiz answers and diagnostic accuracy on their registered lesions with their score on the MCQ? Method: 90 Danish GPs will at baseline, 1 month and end of trial answer a Multiple Choice Questionnaire (MCQ). There is no change to current clinical practice, but all participating doctors will be asked to register a clinical picture and a dermoscopic image as well as basic information about the lesion and patient (age, gender, location and diagnosis) of all skin lesions examined due to a suspicion for non-melanoma or melanoma skin cancer, raised by the GP or patient. GPs in the intervention group are besides the registration application (R-app) given access to an AI augmented training and clinical feedback through an educational smartphone app (E-app). Within the E-app the doctor can access quizzes on a library of 10,000+ skin lesions, written articles about the 40 most common skin lesions, and a clinical feedback module that gives the GP feedback on their registered skin lesions. Feedback on skin lesions with the registered clinical management of referred/excised/biopsied will be provided continuously by independent experts in skin cancer diagnostics (\>10 years of experience) through a web-based review system developed by our group. Feedback on the remaining registered cases are withheld until the end of the study period. This is done to simulate a realistic clinical setting during the study.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04576416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04576416 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Herlev Hospital
- Last refreshed: 25 July 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04576416.
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