Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Basal Cell Carcinoma, Cutaneous Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Real-world demographics in routine clinical practice [Time frame: min. 2 years up to max 5 years of observation]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
1\. Patients receiving treatment within a clinical trial.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Belgium · 1 center
- UZ (Universitair Ziekenhuis) Brüssel — Brussels
Identifiers
NCT: NCT05741073 · Euro-NMSC