Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorEuMelaReg gGmbH
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
1,300 Participants
are grouped into 3 trial groupsGroup A: resected HR-cSCC
Group B: advanced cSCC
Group C: advanced BCC
Trial outcomes
Primary outcomes
1
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.
Time frame
min. 2 years up to max 5 years of observationSecondary outcomes
1
Tumor characteristics
To describe tumor characteristics (pathology, site and stage)
Time frame
min. 2 years up to max 5 years of observation2
Treatment patterns
To evaluate treatment patterns in patients with advanced cSCC, advanced BCC, and completely resected HR-cSCC in routine practice
Time frame
min. 2 years up to max 5 years of observation3
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
Time frame
min. 2 years up to max 5 years of observation4
Adverse drug reactions
To described adverse drug reactions (ADRs)
Time frame
min. 2 years up to max 5 years of observationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov