Early Detection of Skin Tumors Using a Telemedicine Tool in Primary Care
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorInstitute of Health Information and Statistics of the Czech Republic
About this trial
The project is a national, prospective, multicenter, single-arm interventional pilot of screening skin tumors in the Czech Republic.
The primary aim of the project is to methodically prepare, implement and evaluate a pilot project that will verify the suitability of the proposed procedure of early detection of skin tumors by using a telemedicine tools and setting up and testing new methods and implementation into the system of social health care.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
at least 1 suspected lession
phototype I or phototype II
Disqualifiers
skin lession examination by dermatologist in last 12 months
unsigned consent to participate in the project and consent to the processing of personal data
Trial design
Design model
Single group
Treatments tested in this trial
Intervention with telemedicine tool
Diagnostic testThe diagnostic management of enrolled patients will be guided by standardized procedures carried out in general practitioners' offices. Physicians will be trained to identify suspicious skin lesions, capture high-resolution images using dermatoscopes, and transfer the data into advanced telemedicine software. The platform, supported by AI-driven algorithms, enables precise risk stratification of lesions and facilitates remote consultation with collaborating dermatologists. Patients with high-risk lesions will be referred to specialized dermatology centers for further examination and intervention. In cases where excision of a lesion is performed, histopathological assessment will be conducted, and results will be systematically recorded within the dedicated telemedicine platform, ensuring secure and efficient information exchange between dermatologists and general practitioners.
Treatment groups
1,440 Participants
are divided into 1 treatment groupGroup A: Adults with suspected skin lessionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Potential malignancies
Proportion of individuals with a potential presence of malignancy (detected through the telemedicine tool).
Time frame
From enrollment to the end of examination - baseline.2
Confirmed malignancies
Proportion of individuals with confirmed potential malignancy by a dermatologist.
Time frame
From enrollment to the end of diagnosis at 3 months.3
Confirmed malignancies by histology
Proportion of individuals in whom the diagnosis of malignancy was confirmed histologically.
Time frame
From enrollment to the end of diagnosis at 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Institute of Health Information and Statistics of the Czech Republic
Lead sponsor
Vascular surgery, University hospital Královské Vinohrady, Prague
Collaborator
Source ClinicalTrials.gov