Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Melanoma

Pigmentation Disorders

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Patient referred for assessment and excision of their skin lesion, because of a suspicion of melanoma by the referring doctor.

The skin lesion is assessed, diagnosed and triaged by one dermatologist assessors.

Single Assessor Teledermatological triage (TDT)

The skin lesion is assessed, diagnosed and triaged by 2 dermatologist assessors. Worst case overrules.

2 people Teledermatological triage (TDT)

The skin lesion is assessed, diagnosed and triaged by 3 dermatologist assessors. Worst case and majority consensus assessments are calculated separately.

3 people Teledermatological triage (TDT)

The skin lesion is assessed, diagnosed and triaged by 5 dermatologist assessors. Worst case and majority consensus assessments are calculated separately.

5 people Teledermatological triage (TDT)

The goal of this study is to estimate the triage values, efficiency and safety of tele-dermoscopic triage of skin lesions suspected of melanoma. The main question\[s\] it aims to answer are:

* What is the rate of correct patient management by a single, 2, 3 and 5 dermatologists.
* What is the consequence for the patients if teledermoscopic triage is implemented, in termes of missed melanomas and reduced unnecessary excisions/biopsies.

Retrospectively included patients will have their skin lesions re-examined by setups of 1, 2, 3 and 5 tele-dermoscopists who will assign a tentative diagnosis and a recommended clinical action.

The investigators will compare the rate of correct patient management between the different setups.

Background The incidence of melanoma has been increasing in Denmark for decades \[1\]. With an age-standardized rate of 29.7 per 100.000 citizens, Denmark has the third highest melanoma rate in the world, and the highest rate for women (33.6) \[2\].

The excision rate in Danish departments of plastic surgery is close to 100%, although only 46% of referred patients have a malignant tumour \[3\].

To combat this over-treatment, the patient should be triaged by an expert in evaluation of skin tumours as early as possible, who, to a higher degree, could be able to distinguish between benign and malignant skin lesions and dismiss patients with benign lesions without a biopsy.

This triage should therefore be made by subspecialized dermatologists with expertise regarding diagnosing melanocytic skin lesions.

Teledermoscopy has a high sensitivity equal to face-to-face examination \[8\], and images taken in the primary care setting and at the hospital have been found to be of comparable quality \[9\], enabling an accurate assessment of images acquired in the primary care setting.

Our hypothesis is that a mandatory teledermoscopic triage by teledermoscopic experts for all pigmented lesions referred for excision, may reduce the number of unnecessary benign excisions. Yet even the experts may misdiagnose these tricky lesions, and so this study aims to evaluate the management and diagnostic values of a teledermoscopic expert panel on a high-incidence dataset and the safety of the triage method before potential clinical implementation.

Methods Based on a sample size calculation (see Statistics), 250 consecutive patients from the dataset will be included. The patients, whose skin lesions are included in the study, have been referred from PCPs or departments of dermatology at the local public hospitals, but the majority were referred by privately practicing dermatologists.

The teledermatological experts included in this study are dermatologists working mainly with diagnosing melanoma, who have more than 10 years of clinical dermatology experience and have clinical experience with teledermoscopy of melanocytic skin lesions.

Patient and lesion data and images are obtained from the electronic medical record systems Dermloop (Melatech ApS) and Sundhedsplatformen (Epic Systems), used at the Department of Plastic Surgery, Herlev and Gentofte Hospital.

The panel of tele-dermatologists will review all cases and determine a diagnosis and a management. To be able to distinguish primary and secondary outcomes, both a diagnosis and recommended clinical management are required from the experts.

Outcomes The primary outcome of the study is the recommended clinical management, Triage Values, of the TDT panels. The recommended clinical management for each lesion is assessed in binary classification of correct vs incorrect by a list of pre-defined "best practice management" rules based on its histopathological diagnosis outlined in Table 3.

Both a Majority Consensus and a Worst-Case analysis (see Statistics for further explanation) will be done.

In addition, the investigators will report the number of each management option recommended by the different modes of tele-dermatological assessment (single assessor, 2, 3 and 5 assessors).

Secondary outcomes include assessing the diagnostic values (in terms of Sensitivity, Specificity, False Negative and False Positive Rate using the dichotomized histopathological diagnosis of benign vs malignant as Gold Standard) of the TDT expert panel.

The diagnostic accuracy and range are reported separately. For the melanomas in the dataset, a descriptive analysis will me made of how often the tele-dermatologists correctly identify the Breslow thickness, in terms of true positives for each category.

Statistical analysis and Sample Size Calculation In order to discern a disparity between the conventional practice and the diagnostic efficacy of teledermatological assessment, a sample size of 44 cases is sufficient to detect a statistically significant difference, with a level of significance set at 0.05, accompanied by a statistical power of 80%. However, when evaluating the safety of a pure teledermatological triage system, it is imperative to ensure a sufficiently high sensitivity to avoid overlooking melanomas, while concurrently achieving a narrow confidence interval to confidently articulate the findings.

Based on a simulation model using R Studio \[16\] of five teledermoscopy experts diagnosing a number of cases with a 40% prevalence of malignancy with a sensitivity and specificity estimated from previous studies \[8, 17\] an estimated sensitivity of 99% can be found with a narrow confidence interval from 99%-100% with five experts evaluating 250 patient cases. Choosing an uneven number of experts for the panel enables a Majority Consensus analysis and easier interpretation of the results in regard to clinical practice.

Management is ranked hierarchically when defining "worst case" as follows, from least to worst: Dismiss, Dermatological Treatment, Followup, Biopsy, Excision.

Because incongruence between the experts is inevitable, separate analyses will be made using 1) majority consensus (ignoring answers given by less than half of the panel) and 2) "worst-case" consensus (letting even a single expert's suspicion of malignancy or recommendation for a management of a higher rank overrule the rest of the panel).

Perspective This study will report the number of patients that could have avoided having their skin lesions excised and to what degree malignant skin lesions would have been incorrectly managed if the teledermoscopically recommended clinical management had been followed.

The knowledge gained from this study has the potential to significantly change how to diagnose and triage patients suspected of having melanoma, which is the most common type of cancer among young Danes aged 15-34 \[18\].

The results of this and future studies will lead to the excision and treatment of fewer benign skin lesions and pave the way for a smoother patient pathway with less physical referrals, which will benefit not only patients but also lead to potential savings for the healthcare system resources by reducing the number of unnecessary consultations and procedures.

Safety and Avoidance of Futile Excisions Through Skin Tele-triage

Effect of Teledermoscopic Triage on Clinical Management of Skin Lesions Suspected of Melanoma

Sample-size simulation codes, data-analysis codes and deidentified data will be shared through data repository.

Recommended clinical action, correct vs incorrect. Each teledermatologist will recommend a clinical action for each patient case. We evaluate the correctness of this recommended clinical action (in binary classification of correct vs incorrect) by a list of pre-defined "best practice management rules" for each diagnosis.

Secondary outcomes include assessing the diagnostic values (in terms of Sensitivity, Specificity, False Negative and False Positive Rate using the dichotomized histopathological diagnosis of benign vs malignant as Gold Standard) of the TDT expert panel.

Herlev Hospital

Principal Investigator

Dermatologic Agents

All Drugs and Chemicals

The aim of the first part of the study is to evaluate patients' skin monitoring habits, their knowledge of skin cancer, and their preconceptions about new telemedicine tools such as teledermoscopy. This is a written quantitative questionnaire with answers to tick.

An explanatory folder will be given to patients and they will be asked to read it beforehand in order to allow a good understanding of the terms used and the goal of the project. This part will include 70 to 100 patients.

The second part of the study is a qualitative study and the aim of it is to evaluate the satisfaction, acceptance and future expectations of those who have benefited from teledermoscopy. Individual and anonymous interviews, lasting 15 to 20 minutes, intended for patients who have benefit of teledermoscopy at the office. An explanatory folder will also be given to the patients concerned in order to explain to them the procedure of the interview. This part will include 8 to 10 patients.

If there is any diagnostic doubt about a skin lesion, teledermoscopy will be used, if the patient agrees.

* A table containing the useful information about the patient for the lesion's analysis will be completed.
* The pictures will be taken with a Fotofinder Handyscope. The photos will be integrated into the patient's electronic medical record (CareConnect program).
* The photo is anonymized via a serial number assigned by the "Handyscope" application.
* Sending photos and information via a secure email address to the dermatologists.
* Response from the dermatologist (Prof. Tromme or Dr Harkemanne) in the following days also via email.
* Contact (consultation or telephone call depending on the diagnosis) with the patient to communicate the results and the procedure to be followed.
* This information (emails containing the dermatological report) will be saved in the patient's computerized medical file (CareConnect program) then deleted from the mailbox

taking macroscopic and dermoscopic pictures of suspicious skin lesions

Odile MAGOTTEAUX, Dr

Isabelle Tromme, Dr

The aim objective of this work is to assess the characteristics of patients for whom teledermoscopy could be suitable for the detection of potential skin cancers, within a population of rural general medicine in the South of Hainaut, by means of a mixed quantitative and qualitative study corresponding respectively:

* To identify patients' knowledge of skin cancers, their skin monitoring habits, and their acceptability of new telemedicine tools such as teledermoscopy ("Part 1").
* To evaluate the satisfaction and expectations of those who benefit from teledermoscopy ("Part 2").

Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area

Evaluation of Patients Acceptance and Satisfaction With Teledermoscopy at the General Practionner's Office for the Detection of Skin Cancer in a Rural Area.

Using a quantitative survey-type questionnaire

* Determination of the patients ' skin monitoring habits
* Determination of patients' knowledge of skin cancers and their prevention
* Determine their acceptance of new technologies such as teledermoscopy in the context of skin cancer screening
* And finally, determination of a target population for whom teledermoscopy could be suitable for the detection of skin cancers (percentage of patients accepting teledermoscopy etc)

Assessment of the satisfaction and future expectations of patients who have benefited from teledermoscopy in general practice, using a qualitative study in the form of semi-structured, individual and anonymous interviews

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Assessors of teledermoscopy will be randomly assigned to use the results of artificial intelligence when the assess a teledermoscopic case.

Diagnostic algorithms

Asa Ingvar, PhD

Mette Barth

The study has 2 parts. Part 1 will investigate the effects of introducing teledermoscopy in clinical practice, more specifically the change in referral patterns, the risk of undetected skin cancers and the effect on diagnostic accuracy in general practitioners.

Part 2 will investigate how to introduce artificial intelligence (AI) within teledermocsopy. In this study the investigators will measure the diagnostic accuracy of teledermoscopic assessors that had access to the results of artificial intelligence algorithm compared to those who did not.

Data will be collcted through teledermoscopic referrals, patient records, national registries and questionnairs.

Study objective:

1. Is teledermoscopy an equally safe method as conventional care for skin cancer patients? 2. How should teledermoscopy be performed and by whom? 2. How does teledermoscopy affect current care and organization of skin diseases? 3. Can diagnostic algorithms (convolutional neural networks) improve diagnostic accuracy by being a diagnostic support to dermatologists?

Material and methods:

1. Study setting Patients scheduled for a skin examination for a suspected skin lesion can be recruited, both in dermatology clinics and participating primary care clinics or digitally after visiting primary health clinics.
2. Data acquisition Patient data and images will be collected with the Dermicus® application. Participating PCP and dermatologists will also fill in a questionnaire about their assessment of the patient. Additional informaiton will be collected from medical records, i.e. histopathological diagnoses, and from national registries. Questionnaires will be entered in a digital data base using REDCap®.

4. Statistical analyses 4.1. In part 1, the number of consultations send to dermatologists and for pathological analyses before introduction of teledermoscopy and during the first and second year if using teledermoscopy will be analysed. Descriptive statistics will be presented and differences between the different time periods will be tested with t-tests and paired t-tests.

4.2. In part 2, measures of diagnostic accuracy will be estimated comparing dermatologists with and without access to diagnostic algorithm support. Measures reported include sensitivity, specificity, and Area under ROC-curve (AUROC). The study will also report the impact the results of the artificial intelligence has on the willingness to change a diagnosis or a management plan.

5. Power set to 0.8 and significance to 0.05. 10% censures. 5.1. Patients recruited to this study can be used in several of the sub-studies. The aim of the study is to collect 8000 patients in total in this study.

5.2. To detect a difference in "unimaged skin cancers" between teledermoscopy and conventional care of patients 1200 cases and 2400 controls need to be included.

5.3. To detect a 10% difference in sensitivity/ specificity of diagnostic ability in PCPs before and after working with teledermoscopy 3400 patients need to be included.

5.4. To investigate how artificial intelligence should be implemented in clinical care the investigators have calculated that 6000 patients are needed to detect a 10% difference in sensitivity and specificity in the subgroups.

Ethical considerations and data management:

Data will be collected using Dermicus®, a CE-certified digital platform and mobile application. With the application downloaded on iPhones®, locked for any other uses, the history of the patients are registered. Then, by connecting the iPhone to a dermoscope, macroscopic and dermoscopic images are captured. All data will be stored on the servers of the health care region of Skåne, where the studies are conducted. Once a case has been created and sent to the data base all information will be deleted from the iPhone®. Additional data will also be retrieved from relevant medical records, e.g. histopathological diagnosis, and manually registered in an electronic database at a highly secure location (LUSEC/ REDCap provided by Lund University) . Data collected from PCP and dermatologists by questionnaires will also be registered in this data base by means of electronic surveys (REDCap). Information from primary care on total number of visits, referrals to dermatologists and referrals to pathology regarding skin lesions will be extracted from patient administrative systems. Age- and sex matched controls will be used for the study investigating missed skin cancer. These controls will be randomly selected from patients that was referred to a skin clinic by paper referral during the same period as the teledermoscopically referred patients were gathered. Algorithms for skin cancer diagnosis will be implemented in the web platform of Dermicus for the studies of introduction of artificial intelligence. Teledermoscopic assessors will be instructed on when and how to use these different tools.

Every month the newly entered data will be checked for completeness, and in the case of missing data, reminders to participating investigators will be send.

When the data sets are complete, identifiers (such as personal identification number) will be replaced by a code kept secure at a different location than the data set. Data will thereafter be extracted from the data base to perform statistical analysis.

The study is approved by the Swedish Ethical Review Authority and all relevant approvals for data extraction and data storage has been obtained.

Implementation of Teledermoscopy and Artificial Intelligence

Teledermoscopy and Artificial Intelligence: Effects of Implementation in Clinical Practice

Measure how referral patterns are affected by the introduction of teledermoscopy

Measuring if the diagnostic accurcy differs depending on if physician can see the results of the artificial intelligence

Measuring if the risk of undetected skin cancer increases with the use of teledermoscopy

Measuring if the diagnostic accuracy and the willingness to reconsider the preliminary diagnosis differs according to when in the process a physician is presented with the results of the artificial intelligence

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Avoidance of Futile Excisions Through Skin Tele-triage	NCT05982600	Melanoma (Skin) Telemedicine	Single Assessor... 2 people Telede... 3 people Telede... 5 people Telede...	18 Years - 80 Years	Herlev Hospital
Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area	NCT04534868	Skin Cancer Patient Accepta... Patient Satisfa...	taking macrosco...	18 Years -	Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Implementation of Teledermoscopy and Artificial Intelligence	NCT05033678	Skin Cancer	Diagnostic algo...	15 Years -	Region Skane

Spots Global Cancer Trial Database for teledermoscopy