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| Name | Class |
|---|---|
| Capital Medical University | OTHER |
| China-Japan Friendship Hospital | OTHER |
| The First Affiliated Hospital of Zhengzhou University | OTHER |
| The Fourth Hospital of Inner Mongolia Autonomous Region |
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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With immune checkpoint inhibitor-associated venous thromboembolism | Patients with immune checkpoint inhibitor-associated venous thromboembolism would be included in this group | ||
| Without immune checkpoint inhibitor-associated venous thromboembolism | Patients without immune checkpoint inhibitor-associated venous thromboembolism would be included in this group | ||
| With immune checkpoint inhibitor-associated arterial thromboembolism | Patients with immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group | ||
| Without immune checkpoint inhibitor-associated arterial thromboembolism | Patients without immune checkpoint inhibitor-associated arterial thromboembolism would be included in this group |
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| Measure | Description | Time Frame |
|---|---|---|
| Immune checkpoint inhibitor-associated venous thromboembolism/arterial thromboembolism | From the administration of the first dose of immune checkpoint inhibitors until death, initiation of subsequent systemic anticancer therapy other than ICI, or 3 months after the last ICI cycle, symptomatic and incidentally detected arterial thromboembolism and venous thromboembolism events that occur during this period are included. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | Progression-Free Survival refers to the time from the start of immune checkpoint inhibitor therapy until the disease progresses or the patient dies, whichever occurs first. | From the date of the administration of the first dose of immune checkpoint inhibitors until the date of disease progression, death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with histopathologically confirmed lung cancer who were treated with immune checkpoint inhibitors between January 1, 2019, and December 31, 2026.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuhui Zhang | Contact | 86+13520108369 | zhangyhcy@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | China |
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| UNKNOWN |
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Peripheral blood
| Overall survival | Overall survival refers to the time from the start of immune checkpoint inhibitor therapy until the patient dies or the cutoff date, whichever occurs first." | From the date of the administration of the first dose of immune checkpoint inhibitors until the date of death from any cause, or the cutoff date, whichever comes first, assessed up to 96 months. |
| Objective response rate | Objective Response Rate (ORR) refers to the proportion of patients who experience a confirmed reduction in tumor size or complete disappearance of the tumor, as assessed by standard criteria such as RECIST (Response Evaluation Criteria in Solid Tumors). It includes both complete responses (CR) and partial responses (PR) and is typically reported as a percentage of the total treated population. | From the date of the first dose of immune checkpoint inhibitors until the best efficacy is achieved, assessed up to 96 months. |
| The Fourth Hospital of Inner Mongolia Autonomous Region | Recruiting | Hohhot | Inner Mongolia | China |
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| Beijing Chaoyang Hospital, Capital Medical University | Recruiting | Beijing | China |
| Beijing Luhe Hospital, Capital Medical University | Recruiting | Beijing | China |
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| China-japan Friendship Hospital | Recruiting | Beijing | China |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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