Venous Thromboembolism in Advanced Lung Cancer

Study Overview
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Brief Summary
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This is a prospective observatory clinical study, aiming to establish and validate venous thromboembolism risk model in Chinese advanced non-small cell lung cancer.

Detailed Description
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VTE has high incidence in lung cancer and increases the mortality. Appropriate preventive measures contribute to 50% increase of incidence. The investigators are to investigate the VTE in advanced non-small cell lung cancer and delineate the risk factors to establish a VTE risk model system helping clinicians to differentiate VTE high risk population and apply early prevention in order to reduce the incidence of VTE.

Official Title
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Real-world Study of the Incidence and Risk Factors of Venous Thromboembolism (VTE) in Chinese Advanced Stage Lung Cancer

Conditions
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Lung Neoplasms, Venous Thromboembolism

Intervention / Treatment
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* Other: lung cancer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years at the time of screening. Eastern Cooperative Oncology Group performance status of ≤ 2. Written informed consent obtained from the patient. Histologically and cytologically documented Stage 3B-4 lung cancer (according to Version 8 of the International Association for the Study of Lung Cancer Staging system). Patients with stage 1 to 3, who undergo radical therapy with disease free survival (DFS) >12 months. Willingness and ability to comply with scheduled visits and other study procedures. Exclusion Criteria: History of another primary malignancy except for malignancy treated with curative intent with known active disease ≥ 5 years before date of the informed consent. Without signed informed consent. Unwillingness or inability to comply with scheduled visits or other study procedures. Previously diagnosed with VTE before signing informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| advanced lung cancer<br>Patients diagnosed with advanced lung cancer | Other: lung cancer<br>* If the patient is diagnosed with lung cancer in advanced stage, he/she will be followed up for VTE incidence<br>* Other names: advance lung cancer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE incidence risk evaluation | Real world VTE incidence risk evaluation in advanced lung cancer. Establish and validate VTE risk predictive model in Chinese advanced lung cancer. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE incidence | VTE incidence in advanced lung cancer. | 12 months | 
| VTE and overall survival | The influence on overall survival by VTE. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, Venous Thromboembolism