Clinical trial NCT05741073: Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC
Official title: Outcome Research of a European Registry Platform on Real-world Treatment Data of Patients with Advanced NMSC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Basal Cell Carcinoma
Cutaneous Squamous Cell Carcinoma
Lead sponsor: EuMelaReg gGmbH
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥18 years at index date
2. Patients documented in the European NMSC-registry fulfilling EMR quality standard
3. 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.

Primary outcomes:
measure: Real-world demographics in routine clinical practice
timeFrame: min. 2 years up to max 5 years of observation
Secondary outcomes:
measure: Tumor characteristics
timeFrame: min. 2 years up to max 5 years of observation
measure: Treatment patterns
timeFrame: min. 2 years up to max 5 years of observation
measure: Overall survival
timeFrame: min. 2 years up to max 5 years of observation
measure: Adverse drug reactions
timeFrame: min. 2 years up to max 5 years of observation
measure: Treatment discontinuation
timeFrame: min. 2 years up to max 5 years of observation
measure: Time to progression (TTP) - for advanced BCC only
timeFrame: min. 2 years up to max 5 years of observation
measure: Time to progression (TTP) - for advanced cSCC
timeFrame: min. 2 years up to max 5 years of observation
measure: Time to next treatment (TTNT) - for advanced cSCC, advanced BCC only
timeFrame: min. 2 years up to max 5 years of observation
measure: Time to treatment discontinuation (TTD) - for advanced cSCC, advanced BCC only
timeFrame: min. 2 years up to max 5 years of observation
measure: Progression free survival (PFS) - for advanced cSCC, advanced BCC only
timeFrame: min. 2 years up to max 5 years of observation
measure: Overall response rate (ORR) - for advanced cSCC, advanced BCC only
timeFrame: min. 2 years up to max 5 years of observation
measure: Time to recurrence (TTR)
timeFrame: min. 2 years up to max 5 years of observation
measure: Disease Free Survival (DFS)
timeFrame: min. 2 years up to max 5 years of observation
measure: Freedom from distant recurrence (FFDR)
timeFrame: min. 2 years up to max 5 years of observation
measure: Freedom from locoregional recurrence (FFLRR)
timeFrame: min. 2 years up to max 5 years of observation
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ (Universitair Ziekenhuis) Brüssel
Study officials:
References: