Predicting thrombosis risk in lung cancer patients on immune therapy
Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
Beijing Chao Yang Hospital · NCT06950697
This study is trying to see if certain factors can help predict the risk of blood clots in lung cancer patients receiving immune therapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beijing Chao Yang Hospital (other) |
| Locations | 5 sites (Zhengzhou, Henan and 4 other locations) |
| Trial ID | NCT06950697 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the incidence and risk factors of venous and arterial thromboembolism (VTE/ATE) in lung cancer patients treated with immune checkpoint inhibitors (ICIs). Researchers will analyze the relationship between these thrombotic events and therapeutic outcomes to understand their impact on patient prognosis. By comparing characteristics and biomarkers of patients with and without ICI-associated VTE/ATE, the study seeks to identify specific biomarkers for thrombotic events. Ultimately, a risk assessment model will be developed to guide prevention and treatment strategies in clinical practice.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of lung cancer who have received at least one dose of a China-approved immune checkpoint inhibitor.
Not a fit: Patients who do not have lung cancer or those who have not received immune checkpoint inhibitors may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for lung cancer patients undergoing immune therapy, potentially enhancing their treatment outcomes.
How similar studies have performed: While this study explores a specific aspect of thromboembolism in lung cancer patients treated with ICIs, similar studies have shown varying degrees of success in identifying risk factors for thrombotic events in cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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: * 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
Where this trial is running
Zhengzhou, Henan and 4 other locations
- The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
- The Fourth Hospital of Inner Mongolia Autonomous Region — Hohhot, Inner Mongolia, China (RECRUITING)
- Beijing Chaoyang Hospital, Capital Medical University — Beijing, China (RECRUITING)
- Beijing Luhe Hospital, Capital Medical University — Beijing, China (RECRUITING)
- China-japan Friendship Hospital — Beijing, China (RECRUITING)
Study contacts
- Study coordinator: Yuhui Zhang
- Email: zhangyhcy@163.com
- Phone: 86+13520108369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lung Cancer, Venous Thromboembolism, Arterial Thromboembolism, Immune Checkpoint Inhibitors