Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Disease epidemiology
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Additional medical condition(s)

Merkel cell carcinoma
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Special population of interest

Immunocompromised

Estimated number of subjects

1000
Study design details

Main study objective

Enlarge ADO MCC Registry by collecting additional data on treatment patterns, comorbidities, concomitant treatments, effectiveness and safety outcomes, HRU and biomarker Information.
This study aims to identify and describe population of MCC patients, their treatment and outcomes in a real-world settings in Germany.

Outcomes

In patients diagnosed with MCC in Germany
• Patient and tumor characteristics
• Background prevalence rates
• MCC-related treatments for all types and lines of therapy since initial diagnosis of MCC
• Relevant common comorbidities in patients with metastatic stage disease
• Concomitant medications
• Disease outcomes by means of response and survival analyses
• Safety events of interest

Data analysis plan

All statistical analysis will be done using SAS version 9.4 or higher. For categorical variables, summary tabulations of number and percentage within each category (with a category for missing data) of parameter will be presented. For continuous variables, mean, median, standard deviation, minimum and maximum values will be given. All time-to-event analyses will be performed by using Kaplan-Meier methods including calculation of median survival times and 95% confidence intervals (CIs).
Safety analysis will mainly involve assessment of incidence rates (e.g. fatal and nonfatal ADRs, rate of immune-related ADRs).
In addition, as this is an open cohort, accumulation of evidence will continue over the study duration. Data will be analyzed every 6 months as information from more patients is accumulated over the 5-year study period.
The study sponsor will also be able to perform ad hoc queries using the cohort data throughout the duration of the study period of 5 years.
Documents
Study report
English (1.94 MB - PDF)View document