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Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

About this study

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.

Condition
Lung Cancer, Venous Thromboembolism, Arterial Thromboembolism, Immune Checkpoint Inhibitors (ICIs)
Sponsor
Beijing Chao Yang Hospital

Who can join

Age
18 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 6

  • Minimum age: 18 years
  • Study condition: Lung Cancer, Venous Thromboembolism, Arterial Thromboembolism, Immune Checkpoint Inhibitors (ICIs)
  • 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 4

  • 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

5 sites, 5 recruiting

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Recruiting

Beijing Luhe Hospital, Capital Medical University

Beijing, China

Recruiting

China-japan Friendship Hospital

Beijing, China

Recruiting

The Fourth Hospital of Inner Mongolia Autonomous Region

Hohhot, Inner Mongolia, China

Recruiting

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.