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

March 25, 2026 updated by: Institute of Health Information and Statistics of the Czech Republic

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Brno, Czechia
        • Not yet recruiting
        • St. Anne's University Hospital Brno
        • Contact:
      • Olomouc, Czechia
      • Pilsen, Czechia
        • Not yet recruiting
        • University Hospital Pilsen
        • Contact:
      • Prague, Czechia
        • Recruiting
        • Bulovka University Hospital
        • Contact:
      • Prague, Czechia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Adults with suspected skin lession
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.
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-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the end of examination - baseline.
Confirmed malignancies
Time Frame: From enrollment to the end of diagnosis at 3 months.
Proportion of individuals with confirmed potential malignancy by a dermatologist.
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.
Proportion of individuals in whom the diagnosis of malignancy was confirmed histologically.
From enrollment to the end of diagnosis at 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Health Information and Statistics of the Czech Republic

Collaborators

University Hospital Kralovske Vinohrady

Investigators

  • Study Director: Petr Arenberger, prof., Hospital university Kralovske Vinohrady

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

January 13, 2026

First Posted (Actual)

January 20, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UZIS 2025/6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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