The AISC-GP Trial is the first clinical trial of the educational intervention on doctors
Merging the needs of the GP with good clinical research
In the early development of the study protocol Gustav has been doing field research at the GP’s office. The mission was to evaluate how to conduct the best and most feasible research with high study participant compliance and low participant strain. This field research has led to the development of several iterations to the DermLoop Capture registration flow as well as the development of additional features to the DermLoop Learn module.
Randomized Clinical Trial
The trial is a twist on the classic randomized controlled trial. The AISC-GP Trial has the standard setup of an intervention and a control group, but with an allocation ratio of 3:1.
This allocation allows for further subgroup analysis.
The intervention group is given access to the DermLoop Learn education platform and will be given continues feedback on all skin lesions they register as being referred or excised.
The control group is asked to register all suspicious skin lesions using DermLoop Capture, but will not receive access to DermLoop Learn or their clinical feedback during the study period of 3 months. After the study period the control group is given all their clinical feedback, a rapport on their diagnostic accuracy and access to DermLoop Learn and Capture.
We expect to initiate a pilot study in January and February of 2021, to mitigate any kinks and unforeseen obstacles to the trial protocol, and to gather data for a more refined power-calculation.
The AISC-GP Trial is planned to start enrolling participating doctors in April 2022.
Aim and expectations
The study will measure how many hours of educational activity (measured as hours spent with the DermLoop Learn module) it requires for the population of general practitioners to acquire an increase in their diagnostic accuracy in regards to skin and mole cancer.
The hypothesis is that depending on the initial diagnostic accuracy it takes but a few days of full time study to achieve expert competence.
Approvals and registrations
The trial has been reviewed and deemed ready to initiate by the Danish Committee System on Health Research Ethics, Journal-nr.: H-20059977.
The trials is registered at ClinicalTrials.Gov at NCT04576416.
Gustav is full time researcher and Ph.D. student in the AISC consortium, and focuses on the clinical validation and implementation of the educational platform.
This is the trial that kickstarts my Ph.D. and is the first clinical large-scale test of the DermLoop modules. A lot of groundwork, sweat and tears have gone into making this happen.
I’m quite excited!Gustav Gede Nervil
+45 3868 9236
The Research Unit at the Department of Plastic Surgery
Ground Floor, Entrance 7
Borgmester Ib Juuls Vej 7