Clinical trial · Observational
Development and Application of a Thrombosis Risk Prediction Model in Lung Cancer Patients Treated With Immune Checkpoint Inhibitors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arterial Thromboembolism | — | UNRESOLVED | — |
| Immune Checkpoint Inhibitors (ICIs) | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (4)
- label
- With immune checkpoint inhibitor-associated venous thromboembolism
- description
- Patients with immune checkpoint inhibitor-associated venous thromboembolism would be included in this group
- label
- Without immune checkpoint inhibitor-associated venous thromboembolism
- description
- Patients without immune checkpoint inhibitor-associated venous thromboembolism would be included in this group
- label
- With immune checkpoint inhibitor-associated arterial thromboembolism
- description
- Patients with immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group
- label
- Without immune checkpoint inhibitor-associated arterial thromboembolism
- description
- Patients without immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available