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NCT Number: NCT07349940

Early Detection of Skin Tumors Using a Telemedicine Tool in Primary Care

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.

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Key information

Conditions

Skin Cancer Prevention Melanoma Melanoma In Situ Mole (Dermatology) Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Nevus Skin Cancer Skin Diseases Skin Lesions Skin Neoplasms Skin and Connective Tissue Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Anne's University Hospital Brno, Brno, Czechia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • at least 1 suspected lession
  • phototype I or phototype II

Exclusion criteria

  • skin lession examination by dermatologist in last 12 months
  • unsigned consent to participate in the project and consent to the processing of personal data

Treatment and study plan

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.

Primary outcomes

  1. Potential malignancies

    Time frame: From enrollment to the end of examination - baseline.

    Proportion of individuals with a potential presence of malignancy (detected through the telemedicine tool).

  2. Confirmed malignancies

    Time frame: From enrollment to the end of diagnosis at 3 months.

    Proportion of individuals with confirmed potential malignancy by a dermatologist.

  3. Confirmed malignancies by histology

    Time frame: From enrollment to the end of diagnosis at 6 months.

    Proportion of individuals in whom the diagnosis of malignancy was confirmed histologically.

Study contacts

Contact information is provided by the study sponsor or research team.

Dagmar Obšilová, Msc

CONTACT

[email protected]

+420606429382

Lucie Mandelova, Ph.D.

CONTACT

[email protected]

+420 770190 828

Sponsors and collaborators

Lead sponsor

Institute of Health Information and Statistics of the Czech Republic

Other Gov

Collaborators

  • Vascular surgery, University hospital Královské Vinohrady, Prague

Registry information

Acronym: MEL

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 20, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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