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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2027-12-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Cancer Venous Thromboembolism Arterial Thromboembolism

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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with immune checkpoint inhibitor-associated venous thromboembolism

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

No interventions assigned to this group

without immune checkpoint inhibitor-associated venous thromboembolism

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

No interventions assigned to this group

with immune checkpoint inhibitor-associated arterial thromboembolism

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

No interventions assigned to this group

without immune checkpoint inhibitor-associated arterial thromboembolism

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

No interventions assigned to this group

Eligibility Criteria

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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

* Cannot comply with follow-up requirements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No