Melanoma (Skin)NCT05661370
App Teaches Doctors to Diagnose Skin Cancer
A study testing Dermloop Learn in people with Melanoma (Skin) and Carcinoma, run by Herlev Hospital at 1 site in Denmark.
Trial summary
This study aimed to examine if self-paced learning with a novel digital patient-case-based educational platform can increase primary care physicians' diagnostic accuracy of malignant and benign skin lesions on both the level of benign/malignant and the diagnosis level. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin), Carcinoma
- What is being tested?
- Dermloop Learn
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Nov 2021to 15 Aug 2022
- 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 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary Care Physician who works in General Practice
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Diagnostic Accuracy in Skin Cancer Diagnostics Using Educational Mobile App: a Randomized Controlled Study
This study aimed to examine if self-paced learning with a novel digital patient-case-based educational platform can increase primary care physicians' diagnostic accuracy of malignant and benign skin lesions on both the level of benign/malignant and the diagnosis level. Secondarily the study aimed to investigate the time spent in reaching this change in proficiency.
Read the detailed description
Participants were given a questionnaire and an initial Skin Cancer Multiple Choice-Questionnaire (MCQ) to test their diagnostic skills regardining skin and mole cancer and the most common differential diagnoses.
Participants in the Intervention group was then given access to an educational mobile application (App) for 8 days and asked to diagnose 500 patient cases. The participants did so at their own leisure and time.
After 8 days they were asked to abstain from using the App for another 8 days (wash out period) and were then given a Final Skin Cancer Multiple Choice-Questionnaire (MCQ).
Participants of the control group received no intervention nor education during the 16 days of waiting before they took the final Skin Cancer Multiple Choice-Questionnaire.
- Conditions
- Melanoma (Skin), Carcinoma
- Being tested
- Dermloop Learn
- Keywords
- Digital Learning, e-learning, Melanoma, Carcinoma, Dermoscopy, Dermloop
- Medical subject headings
- Melanoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermloop LearnOther
Educational Mobile Application with a library of digital patient-cases and written learning modules the user can access on 36 common skin lesions, both benign and malignant.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Access to educational mobile application for 8 days, diagnosing 500 digital patient-cases. Receives: Other: Dermloop Learn |
| Control | No intervention | Control group receiving no intervention, continuing daily practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multiple-Choice Questionnaire (MCQ) Score
Participants are given a test before and after the intervention using a skin cancer MCQ test with 12 digital-patient cases. A higher score means better diagnostic proficiency. The primary outcome is the change of this score.
Measured: Before and immediately after intervention (On average 19 days after enrollment)
Secondary outcomes (2)
Diagnostic proficiencies
Sensitivity, Specificity and Positive Predictive Value of the participants in the intervention group, calculated on their cases seen in the educational mobile application.
Measured: During the 8 days of access to the educational mobile application.
Time spend
The Dermloop Learn app tracks how much time each user spends quizzing and reading.
Measured: During the 8 days of access to the educational mobile application.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start15 Nov 2021
- Primary completion15 Jan 2022
- Study completion15 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Melanoma (Skin)Studies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention and Controlgroup parallel design using sequential continues block randomization.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gustav Gede Nervil, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661370
- Sponsor's protocol ID
- GP-Learn
- Status last verified
- Jul 2023
- First submitted
- 5 Dec 2022
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participant quiz-answer data can be shared upon reasonable request.
Publications
Nervil GG, Ternov NK, Vestergaard T, Solvsten H, Chakera AH, Tolsgaard MG, Holmich LR. Improving Skin Cancer Diagnostics Through a Mobile App With a Large Interactive Image Repository: Randomized Controlled Trial. JMIR Dermatol. 2023 Aug 9;6:e48357. doi: 10.2196/48357.
PubMed 37624707
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diagnostic Accuracy in Skin Cancer Diagnostics Using Educational Mobile App: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05661370
- Acronym / sponsor ID
- GP-Learn
- Conditions
- Melanoma (Skin), Carcinoma
- Keywords
- Digital Learning, e-learning, Melanoma, Carcinoma, Dermoscopy, Dermloop
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Aug 2022 (actual)
- First posted
- 22 Dec 2022 (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.
This study aimed to examine if self-paced learning with a novel digital patient-case-based educational platform can increase primary care physicians' diagnostic accuracy of malignant and benign skin lesions on both the level of benign/malignant and the diagnosis level. Secondarily the study aimed to investigate the time spent in reaching this change in proficiency.
Detailed description
Participants were given a questionnaire and an initial Skin Cancer Multiple Choice-Questionnaire (MCQ) to test their diagnostic skills regardining skin and mole cancer and the most common differential diagnoses.
Participants in the Intervention group was then given access to an educational mobile application (App) for 8 days and asked to diagnose 500 patient cases. The participants did so at their own leisure and time.
After 8 days they were asked to abstain from using the App for another 8 days (wash out period) and were then given a Final Skin Cancer Multiple Choice-Questionnaire (MCQ).
Participants of the control group received no intervention nor education during the 16 days of waiting before they took the final Skin Cancer Multiple Choice-Questionnaire.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention and Controlgroup parallel design using sequential continues block randomization.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Dermloop LearnAccess to educational mobile application for 8 days, diagnosing 500 digital patient-cases. |
| Control | No intervention | –Control group receiving no intervention, continuing daily practice. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary Care Physician who works in General Practice
Key exclusion criteria (1 listed)
- -
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 LearnEducational Mobile Application with a library of digital patient-cases and written learning modules the user can access on 36 common skin lesions, both benign and malignant. | Other | Intervention |
Primary outcome
Multiple-Choice Questionnaire (MCQ) Score
Time frame: Before and immediately after intervention (On average 19 days after enrollment)
Participants are given a test before and after the intervention using a skin cancer MCQ test with 12 digital-patient cases. A higher score means better diagnostic proficiency. The primary outcome is the change of this score.
2 secondary outcomes
Diagnostic proficiencies
Time frame: During the 8 days of access to the educational mobile application.
Time spend
Time frame: During the 8 days of access to the educational mobile application.
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 24 Jul 2023.
- Derived from this study: PubMed 37624707Nervil GG, Ternov NK, Vestergaard T, Solvsten H, Chakera AH, Tolsgaard MG, Holmich LR. Improving Skin Cancer Diagnostics Through a Mobile App With a Large Interactive Image Repository: Randomized Controlled Trial. JMIR Dermatol. 2023 Aug 9;6:e48357. doi: 10.2196/48357.
- Individual participant dataSharing planned: Yes. Participant quiz-answer data can be shared upon reasonable request.
Related trials for Melanoma (Skin)
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 1
A Feasibility Study Utilizing Immune Recall to Increase Response to Checkpoint Therapy
Melanoma
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (Skin) and Carcinoma, run by Herlev Hospital at 1 site 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 1 inclusion and 1 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 24 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Multiple-Choice Questionnaire (MCQ) Score (time frame: Before and immediately after intervention (On average 19 days after enrollment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05661370, which also lists 1 linked publication.
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 24 Jul 2023.