AI Augmented Training for Skin Specialists (AISC-SS)

October 14, 2024 updated by: Gustav Gede Nervil, Herlev Hospital

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.

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?

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2730
        • Herlev Hospital
      • Copenhagen, Denmark, 2900
        • Gentofte Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Group A
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
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.
No Intervention: Group B

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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Dose/Response
Time Frame: 2 years
Dose/response between hours spent with the education system and change in diagnostic accuracy for the participating doctors
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
BMR
Time Frame: 2 years
Difference in Benign to Malignant ratio (BMR) in treated/referred/sent home lesions suspected of skin cancer.
2 years
Multiple-Choice-Questionnaire predictability of diagnostic accuracy
Time Frame: 2 months
Correlation between diagnostic accuracy and score measured on the MCQ at baseline and at 0 and 2 months.
2 months
Referrals
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Herlev Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gustav G Nervil, MD, Herlev Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AISC-SS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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