Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Recruiting · NCT06950697 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- 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
Exclusion criteria
- 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
Where it is running
5 locations listed.
- Beijing Chaoyang Hospital, Capital Medical University - Beijing, China
- Beijing Luhe Hospital, Capital Medical University - Beijing, China
- China-japan Friendship Hospital - Beijing, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- The Fourth Hospital of Inner Mongolia Autonomous Region - Hohhot, Inner Mongolia, China