MelanomaAISC-SSNCT04758988
AI Augmented Training for Skin Specialists
A study testing DermLoop Learn in people with Melanoma and Skin Cancer, run by Herlev Hospital at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Melanoma, Skin Cancer
- What is being tested?
- DermLoop Learn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- 2 sitesDenmark
- Study dates
- 15 Sep 2021to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Doctors are required to work at a specialized skin department (dermatology or plastic surgery or the like).
- Doctors must be registered authorized health personnel
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Herlev Hospital
Copenhagen, 2730
Gentofte Hospital
Copenhagen, 2900
About this study
Official title: Artificial Intelligence Augmented Training in Skin Cancer Diagnostics for Skin Cancer Specialists
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.
Read more
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?
Read the detailed description
Design:
This study is a superiority trial designed as an international multicenter randomized controlled trial of doctors in highly specialized centers that diagnose and/or treat skin- and mole cancer.
Randomization Eligible participants will be randomized into either the intervention or control group, ratio 1:1.
Intervention:
The participants of group A are given access to a digital educational online system developed by the research group, are asked to register all skin lesions seen with a registration app (clinical and dermoscopic photos and clinical data), also developed by the research group, and will be given clinical feedback on every registered skin lesion.
Participants in group B are also asked from day one to register all skin lesions and will receive feedback on these as the participants of group A, but are withheld their access to the digital educational online system for 2 months.
Feedback on removed/biopsied skin lesions is given directly from the pathologist, who in turn are given easy access to photographs and clinical data of the patient and skin lesion in question.
Statistics:
The average increase in diagnostic accuracy for the population of participating doctors as an effect of the hours spent with the digital educational online system is calculated using Generalized Estimating Equations (GEE).
As benign lesions can be excised/treated for other reasons than suspicion of malignancy we will analyze correctly diagnosed benign lesions treated for different reasons (cosmetic or functional complaints etc.) separately.
We expect a majority of registered lesions to be benign, despite most of the patients already having been seen by GPs before referral.
Ethical considerations:
Patient participation contains no immediate strain or discomfort for the patient, and no change to current clinical practice, as dermoscopic evaluation is part of the clinical examination of skin lesions. The images captured are stored safely and anonymously with no risk for the patient.
With the current low diagnostic accuracy of young doctors the educational nature of the intervention justifies the study for the sake of all future patients with skin lesions that are less likely to be misdiagnosed.
Educational interventions on doctors do not require approval by The National Committee on Health Research Ethics in Denmark. However ethical considerations have been made and the project is in concordance with the Helsinki Declaration II.
- Conditions
- Melanoma, Skin Cancer
- Being tested
- DermLoop Learn
- Keywords
- Artificial Intelligence, Education, Diagnostic Accuracy, Skin Cancer, Melanoma, Feedback loop
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DermLoop LearnOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose/Response
Dose/response between hours spent with the education system and change in diagnostic accuracy for the participating doctors
Measured: 2 years
Secondary outcomes (3)
BMR
Difference in Benign to Malignant ratio (BMR) in treated/referred/sent home lesions suspected of skin cancer.
Measured: 2 years
Multiple-Choice-Questionnaire predictability of diagnostic accuracy
Correlation between diagnostic accuracy and score measured on the MCQ at baseline and at 0 and 2 months.
Measured: 2 months
Referrals
Change in the amount of referrals between the control and intervention group of the departments of dermatology to the departments of plastic surgery in the time before and after the intervention.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2021
- Study start15 Sep 2021
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized superiority clinical trial. Participating doctors are randomized to either group A or B in a 1:1 ratio.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustav Gede Nervil, Herlev Hospital
- Investigators
- Gustav G Nervil, MD, Principal investigator, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04758988
- Sponsor's protocol ID
- AISC-SS
- Acronym
- AISC-SS
- Status last verified
- Oct 2024
- First submitted
- 12 Feb 2021
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Augmented Training in Skin Cancer Diagnostics for Skin Cancer Specialists
- ClinicalTrials.gov ID
- NCT04758988
- Acronym / sponsor ID
- AISC-SS / AISC-SS
- Conditions
- Melanoma, Skin Cancer
- Keywords
- Artificial Intelligence, Education, Diagnostic Accuracy, Skin Cancer, Melanoma, Feedback loop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 17 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Design:
This study is a superiority trial designed as an international multicenter randomized controlled trial of doctors in highly specialized centers that diagnose and/or treat skin- and mole cancer.
Randomization Eligible participants will be randomized into either the intervention or control group, ratio 1:1.
Intervention:
The participants of group A are given access to a digital educational online system developed by the research group, are asked to register all skin lesions seen with a registration app (clinical and dermoscopic photos and clinical data), also developed by the research group, and will be given clinical feedback on every registered skin lesion.
Participants in group B are also asked from day one to register all skin lesions and will receive feedback on these as the participants of group A, but are withheld their access to the digital educational online system for 2 months.
Feedback on removed/biopsied skin lesions is given directly from the pathologist, who in turn are given easy access to photographs and clinical data of the patient and skin lesion in question.
Statistics:
The average increase in diagnostic accuracy for the population of participating doctors as an effect of the hours spent with the digital educational online system is calculated using Generalized Estimating Equations (GEE).
As benign lesions can be excised/treated for other reasons than suspicion of malignancy we will analyze correctly diagnosed benign lesions treated for different reasons (cosmetic or functional complaints etc.) separately.
We expect a majority of registered lesions to be benign, despite most of the patients already having been seen by GPs before referral.
Ethical considerations:
Patient participation contains no immediate strain or discomfort for the patient, and no change to current clinical practice, as dermoscopic evaluation is part of the clinical examination of skin lesions. The images captured are stored safely and anonymously with no risk for the patient.
With the current low diagnostic accuracy of young doctors the educational nature of the intervention justifies the study for the sake of all future patients with skin lesions that are less likely to be misdiagnosed.
Educational interventions on doctors do not require approval by The National Committee on Health Research Ethics in Denmark. However ethical considerations have been made and the project is in concordance with the Helsinki Declaration II.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized superiority clinical trial. Participating doctors are randomized to either group A or B in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Group A | Other | Other: DermLoop LearnThis 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Doctors are required to work at a specialized skin department (dermatology or plastic surgery or the like).
- Doctors must be registered authorized health personnel
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DermLoop LearnDermLoop 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. | Other | Group A |
Primary outcome
Dose/Response
Time frame: 2 years
Dose/response between hours spent with the education system and change in diagnostic accuracy for the participating doctors
3 secondary outcomes
BMR
Time frame: 2 years
Multiple-Choice-Questionnaire predictability of diagnostic accuracy
Time frame: 2 months
Referrals
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gustav G Nervil, MD principal investigator
Herlev Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DermLoop Learn in people with Melanoma and Skin Cancer, run by Herlev Hospital at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose/Response (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024; AzTrials last refreshed its copy on 29 Oct 2026.