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

Sponsor
Beijing Chao Yang Hospital
Study ID
NCT06950697
Status
Recruiting
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Conditions

  • Arterial Thromboembolism
  • Immune Checkpoint Inhibitors (ICIs)
  • Lung Cancer
  • Venous Thromboembolism

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Apr 30, 2025
Start date
Jan 1, 2019
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
2,400 participants (estimated)

Arms

  • Arm: With immune checkpoint inhibitor-associated venous thromboembolism
    Patients with immune checkpoint inhibitor-associated venous thromboembolism would be included in this group
  • Arm: Without immune checkpoint inhibitor-associated venous thromboembolism
    Patients without immune checkpoint inhibitor-associated venous thromboembolism would be included in this group
  • Arm: With immune checkpoint inhibitor-associated arterial thromboembolism
    Patients with immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group
  • Arm: Without immune checkpoint inhibitor-associated arterial thromboembolism
    Patients without immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group

Primary Outcome Measure

Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism [ Time Frame: Begin on the date of the first ICI dose and end upon death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, whichever comes first, assessed up to 96 months. ]

Central Contacts

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