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

NCT07349940 | Recruiting

• 1 other identifier: UZIS 2025/6
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Skin Cancer Prevention; Melanoma In Situ; Skin Lesions; Skin Cancer; Mole (Dermatology)

Keywords

skin cancer; melanoma; telemedicine tool; skin tumors

Outcome Measures

Primary Outcomes (3)

• 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.

Study Arms (1)

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.

Diagnostic Test: Intervention with telemedicine tool

Interventions

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.

Adults with suspected skin lession

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Health Information and Statistics of the Czech Republic: lead
• University Hospital Kralovske Vinohrady: collaborator

Study Sites (5)

St. Anne's University Hospital Brno

Brno, Czechia

NOT YET RECRUITING

Olomouc University Hospital

Olomouc, Czechia

RECRUITING

University Hospital Pilsen

Pilsen, Czechia

NOT YET RECRUITING

Bulovka University Hospital

Prague, Czechia

RECRUITING

University hospital Kralovske Vinohrady

Prague, Czechia

NOT YET RECRUITING

MeSH Terms

Conditions

Skin Neoplasms; Nevus; Melanoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Nevi and Melanomas; Neoplasms by Histologic Type; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue

Study Officials

• Petr Arenberger, prof.

  Hospital university Kralovske Vinohrady

  STUDY DIRECTOR

Central Study Contacts

Dagmar Obšilová, Msc

CONTACT

+420606429382; dagmar.obsilova@uzis.cz

Lucie Mandelova, Ph.D.

CONTACT

+420 770190 828; lucie.mandelova@uzis.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: January 20, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5)