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

Capital Medical University

Status: Enrolling

Conditions: Venous Thromboembolism; Lung Cancer; Arterial Thromboembolism

Study type: Observational

Funder types: Other

Identifiers

NCT06950697

CYHF202212

Details and patient eligibility

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 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.

Enrollment: 2,400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

• Excluded based on inclusion criteria
• Cannot comply with follow-up requirements

Trial design

2,400 participants in 4 patient groups

with immune checkpoint inhibitor-associated venous thromboembolism

Description:

patients with immune checkpoint inhibitor-associated venous thromboembolism would be included in this group

without immune checkpoint inhibitor-associated venous thromboembolism

Description:

patients without immune checkpoint inhibitor-associated venous thromboembolism would be included in this group

with immune checkpoint inhibitor-associated arterial thromboembolism

Description:

patients with immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group

without immune checkpoint inhibitor-associated arterial thromboembolism

Description:

patients without immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group