About this trial
The purpose of this observational study is to explore the incidence, risk factors, and relationship with therapeutic outcomes of VTE (venous thromboembolism) and ATE (arterial thromboembolism) associated with immune checkpoint inhibitors (ICIs) therapy. The primary questions it aims to address are:
1. What is the real-world incidence of VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 2. What are the risk factors and biomarkers for VTE/ATE in lung cancer patients receiving immune checkpoint inhibitors? 3. What is the impact of VTE/ATE on the prognosis of lung cancer patients receiving immune checkpoint inhibitors?
Researchers will compare the characteristics and biomarkers of patients with and without ICI-associated VTE/ATE to identify novel specific biomarkers for thrombotic events. Furthermore, they will construct a risk assessment model for thrombotic events to provide guidance for precision prevention and treatment in clinical practice.
Eligibility criteria
Qualifiers
Age ≥18 years
Histopathologically confirmed lung cancer diagnosis at enrollment
Received at least one dose of a China-approved lung cancer immune checkpoint inhibitor
Signed informed consent form
Disqualifiers
Presence of two or more primary cancers
Missing data for key variables
Inability to comply with follow-up requirements
Presence of VTE/ATE at the time of ICI initiation
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Beijing Chao Yang Hospital
Lead sponsor
Capital Medical University
Collaborator
China-Japan Friendship Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Fourth Hospital of Inner Mongolia Autonomous Region
Collaborator