Prospective observational study of thromboembolic events in patients of advanced stage Non small cell lung cancer(NSCLC) treated with platinum based chemotherapy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 167
- 试验地点
- 1
- 主要终点
- PRIMARY OUTCOME:
研究概览
简要总结
Aims/ Objectives of the study:
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To determine the incidence of thromboembolic events including deep venous thrombosis (DVT), pulmonary embolus (PE), cerebrovascular accident, and unstable angina/myocardial infarction (MI) in patients of lung cancer treated with platinum-based chemotherapy.
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To analyze the prognostic value of patients’ baseline and treatment characteristics in predicting occurrence of thromboembolic events in patients of lung cancer on platinum based chemotherapy.
Study methodology:
1.All patients will be evaluated at the baseline prior to start of chemotherapy by taking a detailed history and detailed physical examination.
2.Baseline characteristics of the patients will be noted including sex, BMI ,performance status , hemoglobin, total leucocyte count, platelet count and will be assigned to Khorana risk group (low , intermediate or high).
Factors for univariate analysis will be these:
1. BMI ,Smoking ,DM , HTN ,Dyslipidemia ,Baseline hemoglobin, Baseline leucocyte count, Baseline platelet count, Presence of Central venous catheter, Khorana risk score.
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All patients will be enquired for development of any thromboembolic event including at every visit with relevant history pertaining to deep venous thrombosis (DVT), pulmonary embolus (PE), cerebrovascular accident, and unstable angina/myocardial infarction (MI).
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In the presence of a positive history relating to development of any thromboembolic event ,relevant diagnostic tests will be performed for confirmation of the diagnosis as per the treating physician’s decision.5. A thromboembolic event will be considered associated with chemotherapy if it occurred between the time of the first dose of platinum based chemotherapy and 4 weeks after the last dose.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA: Lung cancer patients (age >18 years) who are started on platinum based chemotherapy.
排除标准
- •EXCLUSION CRITERIA:
- •Age <18 years
- •Patients in whom therapy is discontinued prior to completion of 6 weeks due to any reason.
- •Presence of any thromboembolic event before start of chemotherapy including deep venous thrombosis (DVT), pulmonary embolus, cerebrovascular accident, and unstable angina/myocardial infarction (MI).
- •4.Patients with bleeding diathesis, inherited coagulopathy, and those requiring therapeutic anticoagulation, regular nonsteroidal anti-inflammatory drugs, and aspirin.
- •Patients receiving angiogenesis inhibitor drug- bevacizumab.
结局指标
主要结局
PRIMARY OUTCOME:
时间窗: At the baseline and end of the study(4 weeks from the last dose of chemotherapy) or earlier in case of development of a thromboembolic event .
The overall incidence, timing, and characteristics of thromboembolic events (venous or arterial) in adult patients of advanced stage non small cell lung cancer treated with platinum-based chemotherapy.
时间窗: At the baseline and end of the study(4 weeks from the last dose of chemotherapy) or earlier in case of development of a thromboembolic event .
次要结局
- SECONDARY OUTCOME:(Secondary objectives are to analyze the prognostic value of baseline and treatment characteristics in predicting the occurrence of a thromboembolic events in patients of advanced stage non small cell lung cancer treated with platinum-based chemotherapy.)