Skin Cancer PreventionMELNCT07349940
Early Detection of Skin Tumors Using a Telemedicine Tool in Primary Care
A study testing Intervention with telemedicine tool in people with Skin Cancer Prevention and Melanoma In Situ, run by Institute of Health Information and Statistics of the Czech Republic at 5 sites in Czechia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Skin Cancer Prevention, Melanoma In Situ, Skin Lesions
- What is being tested?
- Intervention with telemedicine tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,440 participants
- Where
- 5 sitesCzechia
- Study dates
- 1 Feb 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- at least 1 suspected lession
- phototype I or phototype II
Who cannot join
- skin lession examination by dermatologist in last 12 months
- unsigned consent to participate in the project and consent to the processing of personal data
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Czechia5 sites, 5 recruiting
- Not yet recruiting
St. Anne's University Hospital Brno
Brno
Hana Jedličková, prof., hjedlic@medmuni.cz
- Recruiting
Olomouc University Hospital
Olomouc
Zdeněk Drlík, MD, zdenek.drlik@fnol.cz
- Not yet recruiting
University Hospital Pilsen
Pilsen
Jan Říčař, MD, Ph.D., ricarj@fnplzen.cz
- Recruiting
Bulovka University Hospital
Prague
Filip Rob, Assoc. Prof., filip.rob@bulovka.cz
- Not yet recruiting
University hospital Kralovske Vinohrady
Prague
Petr Arenberger, prof., petr.arenberger@lf3.cuni.cz
About this study
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.
Read the 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.
- Being tested
- Intervention with telemedicine tool
- Keywords
- skin cancer, melanoma, telemedicine tool, skin tumors
- Medical subject headings
- Skin Neoplasms, Nevus, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with telemedicine toolDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Intervention with telemedicine tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Potential malignancies
Proportion of individuals with a potential presence of malignancy (detected through the telemedicine tool).
Measured: From enrollment to the end of examination - baseline.
Confirmed malignancies
Proportion of individuals with confirmed potential malignancy by a dermatologist.
Measured: 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.
Measured: From enrollment to the end of diagnosis at 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Feb 2026
- Primary completion31 Aug 2026
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancer PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Health Information and Statistics of the Czech Republic
- Sponsor type
- Other government
- Collaborators
- Vascular surgery, University hospital Královské Vinohrady, Prague
- Responsible party
- Sponsor
- Investigators
- Petr Arenberger, prof., Study director, Hospital university Kralovske Vinohrady
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07349940
- Sponsor's protocol ID
- UZIS 2025/6
- Acronym
- MEL
- Status last verified
- Nov 2026
- First submitted
- 18 Nov 2025
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Skin Tumors Using a Telemedicine Tool in Primary Care
- ClinicalTrials.gov ID
- NCT07349940
- Acronym / sponsor ID
- MEL / UZIS 2025/6
- Keywords
- skin cancer, melanoma, telemedicine tool, skin tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Institute of Health Information and Statistics of the Czech RepublicOther government
- Collaborators
- Vascular surgery, University hospital Královské Vinohrady, Prague
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with suspected skin lession | Experimental | Diagnostic Test: Intervention with telemedicine toolPilot 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- at least 1 suspected lession
- phototype I or phototype II
Key exclusion criteria (2 listed)
- skin lession examination by dermatologist in last 12 months
- unsigned consent to participate in the project and consent to the processing of personal data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention with telemedicine toolThe 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. | Diagnostic test | Adults with suspected skin lession |
Primary outcome
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).
Confirmed malignancies
Time frame: From enrollment to the end of diagnosis at 3 months.
Proportion of individuals with confirmed potential malignancy by a dermatologist.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Petr Arenberger, prof. study director
Hospital university Kralovske Vinohrady
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with telemedicine tool in people with Skin Cancer Prevention and Melanoma In Situ, run by Institute of Health Information and Statistics of the Czech Republic at 5 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dagmar Obšilová, Msc (+420606429382, dagmar.obsilova@uzis.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Potential malignancies (time frame: From enrollment to the end of examination - baseline.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.