Actively Recruiting

Age: 18Years +
All Genders
ID06950697

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

Led by Beijing Chao Yang Hospital · Updated on 2026-04-30

2400

Participants Needed

5

Research Sites

47 weeks

Total Duration

On this page

Sponsors

B

Beijing Chao Yang Hospital

Lead Sponsor

C

Capital Medical University

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying lung cancer patients receiving immune checkpoint inhibitors (ICIs) to understand how often venous thromboembolism (VTE) and arterial thromboembolism (ATE) occur, what risk factors and biomarkers are involved, and how these events affect patient outcomes. The study aims to identify specific biomarkers linked to thrombotic events and develop a risk prediction model to support personalized prevention and treatment in clinical care. This observational study divides participants into groups based on whether they experience ICI-associated VTE or ATE. Researchers compare patient characteristics and biomarkers between those with and without these thrombotic events to find new markers and risk factors. Data collection begins at the first dose of ICIs and continues until death, the start of other cancer treatments, or three months after the last ICI dose, with follow-up lasting up to 96 months. During the study, participants are monitored for thrombotic events and their impact on progression-free survival, overall survival, and response to treatment. Key outcomes are assessed through clinical data and biomarkers collected over time. The research team tracks these outcomes from treatment start through a long-term follow-up period, aiming to improve understanding of thrombosis risks in lung cancer patients receiving ICIs.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 6528 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
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Monitoring

Duration - Up to 96 months

Participants are monitored from the first dose of immune checkpoint inhibitors until death, start of other systemic anticancer therapy, or 3 months after the last dose, for up to 96 months.

Trial Site Locations

Total: 5 locations

1

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

2

The Fourth Hospital of Inner Mongolia Autonomous Region

Hohhot, Inner Mongolia, China

Actively Recruiting

3

Beijing Chaoyang Hospital, Capital Medical University

Beijing, China

Actively Recruiting

4

Beijing Luhe Hospital, Capital Medical University

Beijing, China

Actively Recruiting

5

China-japan Friendship Hospital

Beijing, China

Actively Recruiting

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Research Team

Y

Yuhui Zhang

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

4

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