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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Chao Yang Hospital

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

2,400 Participants
are grouped into 4 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