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| Name | Class |
|---|---|
| Vascular surgery, University hospital Královské Vinohrady, Prague | OTHER |
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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.
The project is a national, prospective, multicenter, single-arm interventional pilot project for skin tumors screening involving 18 general practitioners and 6 dermatology centers in the Czech Republic.
The main objective of the project is the early detection of skin tumors by general practitioners, increasing the efficiency of healthcare, and methodically preparing, implementing, and evaluating the pilot project. The project aims to verify the suitability of the proposed early detection procedure for skin tumors, as well as to establish and test new methods and integrate them into the healthcare system.
As part of the project, the procedure will be tested on a sample of approximately 1,440 individuals, which may help validate the use of telemedicine tools in healthcare. A methodology for the use of telemedicine tools will be developed, along with a framework for collaboration between general practitioners and affiliated dermatologists. Systemic changes will be proposed to enhance the efficiency of the screening process.
The project is supported by the European Social Fund (Operational Programme Employment Plus) and the state budget of the Czech Republic. It is registered with the Ministry of Labour and Social Affairs of the Czech Republic under ID: CZ.03.02.02/00/22_005/0002008.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with suspected skin lession | Experimental | Pilot screening will be conducted in general practitioners' offices, where physicians will be trained to examine skin lesions using magnifying devices (dermatoscopes) and advanced telemedicine software, enabling faster diagnostics of suspicious findings. Patients with high-risk lesions will be referred to specialized dermatology centers. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention with telemedicine tool | Diagnostic Test | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Potential malignancies | Proportion of individuals with a potential presence of malignancy (detected through the telemedicine tool). | From enrollment to the end of examination - baseline. |
| Confirmed malignancies | Proportion of individuals with confirmed potential malignancy by a dermatologist. | From enrollment to the end of diagnosis at 3 months. |
| Confirmed malignancies by histology | Proportion of individuals in whom the diagnosis of malignancy was confirmed histologically. | From enrollment to the end of diagnosis at 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dagmar Obšilová, Msc | Contact | +420606429382 | dagmar.obsilova@uzis.cz | |
| Lucie Mandelova, Ph.D. | Contact | +420 770190 828 | lucie.mandelova@uzis.cz |
| Name | Affiliation | Role |
|---|---|---|
| Petr Arenberger, prof. | Hospital university Kralovske Vinohrady | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Anne's University Hospital Brno | Not yet recruiting | Brno | Czechia |
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| Olomouc University Hospital | Recruiting | Olomouc | Czechia |
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| University Hospital Pilsen | Not yet recruiting | Pilsen | Czechia |
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| Bulovka University Hospital | Recruiting | Prague | Czechia |
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| University hospital Kralovske Vinohrady | Not yet recruiting | Prague | Czechia |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D009506 | Nevus |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009380 | Neoplasms, Nerve Tissue |
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