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Recruiting NCT07349940

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

No phase Interventional Skin Cancer Prevention Melanoma In Situ Skin Lesions Skin Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention with telemedicine tool.
Who it may be relevant to
Registry conditions: Skin Cancer Prevention, Melanoma In Situ, Skin Lesions, Skin Cancer. Basic parameters: from 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Czechia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

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.

Interventions

  • Diagnostic test Intervention with telemedicine tool
    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-ri

Primary outcome measures

  • Potential malignancies [Time frame: From enrollment to the end of examination - baseline.]
  • Confirmed malignancies [Time frame: From enrollment to the end of diagnosis at 3 months.]
  • Confirmed malignancies by histology [Time frame: From enrollment to the end of diagnosis at 6 months.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Czechia · 5 centers
  • St. Anne's University Hospital Brno — Brno
  • Olomouc University Hospital — Olomouc
  • University Hospital Pilsen — Pilsen
  • Bulovka University Hospital — Prague
  • University hospital Kralovske Vinohrady — Prague

Identifiers

NCT: NCT07349940 · UZIS 2025/6

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗