Basal Cell CarcinomaNCT05741073
Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC
An observational study of Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma, run by EuMelaReg gGmbH at 1 site in Belgium.
Trial summary
This current registry study will analyze real-world data to address questions about disease characteristics and treatment patterns in NMSC patients based on the European NMSC-Registry. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma
- How many people
- 1,300 participants
- Where
- 1 siteBelgium
- Study dates
- 30 Jun 2023to Dec 2027
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with documentation of advanced diagnosis of cSCC/ BCC or with HR-cSCC since AUG 2019 and who fulfill the inclusion and exclusion criteria described below will be included in this registry. Enrollment into all 3 cohorts will be performed concurrently. All patients will be treated according to specifications stated in the respective local/European guidelines of the drugs administered in clinical routine.
Who may be able to join
- Patients aged ≥18 years at index date
- Patients documented in the European NMSC-registry fulfilling EMR quality standard
- Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting OR Patients with advanced cSCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 2) OR Patients with advanced BCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 3)
Who cannot join
- 1. Patients receiving treatment within a clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
UZ (Universitair Ziekenhuis) Brüssel
Brussels
Marthe Verhaert
About this study
This current registry study will analyze real-world data to address questions about disease characteristics and treatment patterns in NMSC patients based on the European NMSC-Registry. The overall objective is to describe characteristics, management and treatment outcomes for patients presenting with advanced NMSC (cSCC/BCC) or HR-cSCC in routine clinical practice, independent of treatments used across different European regions.
Read the detailed description
Skin cancer is one of the most common cancers worldwide, and the most frequent cancer in the white population. Incidence rates of NMSC are increasing, partly attributable to more outdoor leisure activities and aging population. Among NMSC, basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) are the most predominant histologic subtypes. Real-world data especially those systematically recorded in registries are limited. With limited resources, many cancer databases do not register all primary NMSCs. For advanced patients with NMSC, the EUMelaReg consortium (EMR) introduces a registry specific for NMSC across Europe (EMR-NMSC) which brings together national registries and operates as a higher-level registry. The aim of this registry is to collect real-world data of the available diagnosis and treatment pattern of advanced NMSC patients at a European level. Data of the EMR NMSC-Registry can be used for specific pre-defined analyses regarding drugs, availability and affordability of various treatments for different patient populations, data on health-related resource utilization, outcome data, and risk factors.
Quality management Study participating sites are responsible for recording and verifying the accuracy of subject data.
A data management plan (DMP) will be in place which describes the life cycle of the study data from the collection to archiving, including all measures to ensure that the data remain available, usable and comprehensible. It includes rules and regulations for e.g. data validation, data processing, medical coding, quality review procedures and archiving of study documentation. National and international data protection laws as well as regulations on registries will be followed.
Data validation Detailed information on checks for completeness, accuracy, plausibility and validity are given in the data validation plan (DVP). The computerized handling of the data by the service provider may generate requests to which the participating site needs to respond by confirming or modifying the data questioned.
- Medical subject headings
- Carcinoma, Basal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| resected HR-cSCC | Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting | |
| advanced cSCC | Patients with advanced cSCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 2) | |
| advanced BCC | Patients with advanced BCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-world demographics in routine clinical practice
To capture real-world demographics in routine clinical practice, independent of treatment used across different European regions in patients with advanced cSCC, advanced BCC, and completely resected HR-cSCC.
Measured: min. 2 years up to max 5 years of observation
Secondary outcomes (15)
Tumor characteristics
To describe tumor characteristics (pathology, site and stage)
Measured: min. 2 years up to max 5 years of observation
Treatment patterns
To evaluate treatment patterns in patients with advanced cSCC, advanced BCC, and completely resected HR-cSCC in routine practice
Measured: min. 2 years up to max 5 years of observation
Overall survival
To characterize overall survival (OS) from initiation of treatment in the advanced stage (for HR-cSCC: from date of surgery) to date of death due to any cause
Measured: min. 2 years up to max 5 years of observation
Adverse drug reactions
To described adverse drug reactions (ADRs)
Measured: min. 2 years up to max 5 years of observation
Treatment discontinuation
Reason for treatment discontinuation
Measured: min. 2 years up to max 5 years of observation
Time to progression (TTP) - for advanced BCC only
Time to progression (TTP) of first and second line treatment for advanced BCC defined as time from start of treatment to date of progression based on physician's assessment or death due to aBCC.
Measured: min. 2 years up to max 5 years of observation
Time to progression (TTP) - for advanced cSCC
Time to progression (TTP) for advanced cSCC defined as time from start of treatment to date of progression based on physician's assessment or death due to cSCC.
Measured: min. 2 years up to max 5 years of observation
Time to next treatment (TTNT) - for advanced cSCC, advanced BCC only
Time to next treatment (TTNT) defined as the time from the date of treatment initiation in the advanced stage until the next line of treatment.
Measured: min. 2 years up to max 5 years of observation
Time to treatment discontinuation (TTD) - for advanced cSCC, advanced BCC only
Time to treatment discontinuation (TTD), defined as the interval between start of treatment and its permanent discontinuation or death.
Measured: min. 2 years up to max 5 years of observation
Progression free survival (PFS) - for advanced cSCC, advanced BCC only
Progression free survival (PFS) from start of treatment in the advanced stage to progression based on physician's assessment or death due to any cause.
Measured: min. 2 years up to max 5 years of observation
Overall response rate (ORR) - for advanced cSCC, advanced BCC only
Overall response rate (ORR) during first line/second line treatment defined as the proportion of patients with CR or PR as best response according to physician's routine method.
Measured: min. 2 years up to max 5 years of observation
Time to recurrence (TTR)
For resected high-risk cSCC, defined as AJCC 8th edition T class of T3 tumor or any resected N-positive regional disease only:
Time to recurrence (TTR) defined as time from date of R0-surgery to date of recurrence or tumour related death.
Measured: min. 2 years up to max 5 years of observation
Disease Free Survival (DFS)
For resected high-risk cSCC, defined as AJCC 8th edition T class of T3 tumor or any resected N-positive regional disease only:
Disease Free Survival (DFS) defined as period from complete resection to date of relapse or death of any cause.
Measured: min. 2 years up to max 5 years of observation
Freedom from distant recurrence (FFDR)
For resected high-risk cSCC, defined as AJCC 8th edition T class of T3 tumor or any resected N-positive regional disease only:
Freedom from distant recurrence (FFDR) defined as time from date of R0-surgery to date of occurrence of a distant metastasis.
Measured: min. 2 years up to max 5 years of observation
Freedom from locoregional recurrence (FFLRR)
For resected high-risk cSCC, defined as AJCC 8th edition T class of T3 tumor or any resected N-positive regional disease only:
Freedom from locoregional recurrence (FFLRR) defined as time from date of R0-surgery to date of occurrence of a local relapse or locoregional metastasis.
Measured: min. 2 years up to max 5 years of observation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start30 Jun 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basal Cell CarcinomaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- EuMelaReg gGmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05741073
- Sponsor's protocol ID
- Euro-NMSC
- Status last verified
- Mar 2025
- First submitted
- 14 Feb 2023
- Last updated
- 12 Mar 2025
- 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 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC
- ClinicalTrials.gov ID
- NCT05741073
- Acronym / sponsor ID
- Euro-NMSC
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,300 participants (estimated)
- Lead sponsor
- EuMelaReg gGmbHIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 23 Feb 2023 (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.
This current registry study will analyze real-world data to address questions about disease characteristics and treatment patterns in NMSC patients based on the European NMSC-Registry. The overall objective is to describe characteristics, management and treatment outcomes for patients presenting with advanced NMSC (cSCC/BCC) or HR-cSCC in routine clinical practice, independent of treatments used across different European regions.
Detailed description
Skin cancer is one of the most common cancers worldwide, and the most frequent cancer in the white population. Incidence rates of NMSC are increasing, partly attributable to more outdoor leisure activities and aging population. Among NMSC, basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC) are the most predominant histologic subtypes. Real-world data especially those systematically recorded in registries are limited. With limited resources, many cancer databases do not register all primary NMSCs. For advanced patients with NMSC, the EUMelaReg consortium (EMR) introduces a registry specific for NMSC across Europe (EMR-NMSC) which brings together national registries and operates as a higher-level registry. The aim of this registry is to collect real-world data of the available diagnosis and treatment pattern of advanced NMSC patients at a European level. Data of the EMR NMSC-Registry can be used for specific pre-defined analyses regarding drugs, availability and affordability of various treatments for different patient populations, data on health-related resource utilization, outcome data, and risk factors.
Quality management Study participating sites are responsible for recording and verifying the accuracy of subject data.
A data management plan (DMP) will be in place which describes the life cycle of the study data from the collection to archiving, including all measures to ensure that the data remain available, usable and comprehensible. It includes rules and regulations for e.g. data validation, data processing, medical coding, quality review procedures and archiving of study documentation. National and international data protection laws as well as regulations on registries will be followed.
Data validation Detailed information on checks for completeness, accuracy, plausibility and validity are given in the data validation plan (DVP). The computerized handling of the data by the service provider may generate requests to which the participating site needs to respond by confirming or modifying the data questioned.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| resected HR-cSCC | – | –Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting |
| advanced cSCC | – | –Patients with advanced cSCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 2) |
| advanced BCC | – | –Patients with advanced BCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with documentation of advanced diagnosis of cSCC/ BCC or with HR-cSCC since AUG 2019 and who fulfill the inclusion and exclusion criteria described below will be included in this registry. Enrollment into all 3 cohorts will be performed concurrently. All patients will be treated according to specifications stated in the respective local/European guidelines of the drugs administered in clinical routine.
Key inclusion criteria (3 listed)
- Patients aged ≥18 years at index date
- Patients documented in the European NMSC-registry fulfilling EMR quality standard
- Patients with resected HR-cSCC (Cohort 1) receiving only postoperative radiotherapy or watchful waiting OR Patients with advanced cSCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 2) OR Patients with advanced BCC who are not candidates for curative surgery/radiation in routine clinical practice (Cohort 3)
Key exclusion criteria (1 listed)
- 1. Patients receiving treatment within a clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Real-world demographics in routine clinical practice
Time frame: min. 2 years up to max 5 years of observation
To capture real-world demographics in routine clinical practice, independent of treatment used across different European regions in patients with advanced cSCC, advanced BCC, and completely resected HR-cSCC.
15 secondary outcomes
Tumor characteristics
Time frame: min. 2 years up to max 5 years of observation
Treatment patterns
Time frame: min. 2 years up to max 5 years of observation
Overall survival
Time frame: min. 2 years up to max 5 years of observation
Adverse drug reactions
Time frame: min. 2 years up to max 5 years of observation
Treatment discontinuation
Time frame: min. 2 years up to max 5 years of observation
Time to progression (TTP) - for advanced BCC only
Time frame: min. 2 years up to max 5 years of observation
Time to progression (TTP) - for advanced cSCC
Time frame: min. 2 years up to max 5 years of observation
Time to next treatment (TTNT) - for advanced cSCC, advanced BCC only
Time frame: min. 2 years up to max 5 years of observation
Time to treatment discontinuation (TTD) - for advanced cSCC, advanced BCC only
Time frame: min. 2 years up to max 5 years of observation
Progression free survival (PFS) - for advanced cSCC, advanced BCC only
Time frame: min. 2 years up to max 5 years of observation
Overall response rate (ORR) - for advanced cSCC, advanced BCC only
Time frame: min. 2 years up to max 5 years of observation
Time to recurrence (TTR)
Time frame: min. 2 years up to max 5 years of observation
Disease Free Survival (DFS)
Time frame: min. 2 years up to max 5 years of observation
Freedom from distant recurrence (FFDR)
Time frame: min. 2 years up to max 5 years of observation
Freedom from locoregional recurrence (FFLRR)
Time frame: min. 2 years up to max 5 years of observation
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 12 Mar 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Cell Carcinoma and Cutaneous Squamous Cell Carcinoma, run by EuMelaReg gGmbH at 1 site in Belgium.
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 3 inclusion and 1 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 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 Alexandra Hansen (+493037026901, alexandra.hansen@eumelareg.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-world demographics in routine clinical practice (time frame: min. 2 years up to max 5 years of observation). 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 12 Mar 2025.