MD, PhD student
Helene Broch Tenstad
Department of Rheumatology
| Projekt styring | ||
| Projekt status | Open | |
| Data indsamlingsdatoer | ||
| Start | 08.10.2025 | |
| Slut | 13.10.2027 | |
Diagnosis, Treatment, and Prognosis of Patients with Immunotherapy-Related Adverse Events in Denmark: An 11-Year Nationwide Retrospective Descriptive Cohort
Short summary
Immune checkpoint inhibitors improve survival but cause immune-related adverse events (irAEs). This nationwide retrospective cohort (Denmark, 2014-2025) describes diagnosis, management and prognosis of clinically significant irAEs across organs. We link records, imaging, labs and registries to estimate incidence, phenotypes, treatments, complications, treatment changes and survival, generating evidence to refine Danish care pathways.
Rationale
Immune checkpoint inhibitors prolong survival across several cancers but trigger immune-related adverse events (irAEs).¹-³ We will conduct a nationwide retrospective cohort study in Denmark (2014-2025) to describe diagnosis, management, and prognosis of clinically significant irAEs across organ systems. Linking electronic health records from all oncology centers with imaging archives, laboratory networks, and national registries (patient, cancer, prescription, mortality), we will estimate irAE incidence, time-to-onset, phenotypes, severity (CTCAE), treatments, complications, treatment modifications, and survival. Findings will inform risk stratification and refine Danish care pathways and follow-up algorithms for patients receiving checkpoint blockade.
Description of the cohort
Eligible patients are those managed in oncology departments across four Danish regions-Southern Denmark, Capital, Central Denmark, and North Denmark-with an expected cohort of ~15,000 individuals. We will begin data abstraction with malignant melanoma and subsequently extend to other tumour types.
Data and biological material
patient journal information
Collaborating researchers and departments
Department of Oncology Odense University Hospital