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临床试验/NCT02604667
NCT02604667已完成不适用

Mechanisms of Ischemic Stroke in Cancer Patients

Weill Medical College of Cornell University2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2016年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Hematological biomarker levels

研究概览

简要总结

The purpose of this study is to better understand the causes of stroke in people with cancer. Active cancer increases the risk of stroke. The investigators do not know exactly why this occurs but one possible reason is that people with cancer may have thicker blood than people without cancer. Thick blood can sometimes cause blood clots to form in the heart, which can then travel to the brain and cause stroke. This study is being done to help figure out why this and other causes of stroke occur in people with cancer. The investigators expect that information from this study will help doctors to more effectively prevent and treat stroke in individuals with cancer.

详细描述

This will be a prospective cross-sectional study to examine the unique mechanisms of ischemic stroke in cancer patients. Enrollment will occur at the NewYork-Presbyterian Hospital (NYPH)/Weill Cornell Medical Center (WCMC) and the Memorial Sloan Kettering Cancer Center (MSKCC). Measurements will occur at the NYPH/WCMC and MSKCC Neurovascular Ultrasound Laboratories, the MSKCC Central Laboratory, and the Sharp Laboratory at the University of California, Davis. Three groups of adult patients will be enrolled. Group 1 will consist of consecutive patients with active solid tumor cancer and acute ischemic stroke. Group 2 will be patients with acute ischemic stroke and no cancer. Patients in Groups 1 and 2 will be enrolled at 96 hours +/- 24 hours of stroke onset. Group 3 will include patients with active solid tumor cancer and no stroke. This group will allow us to confirm that differences between stroke patients with and without cancer are not simply incidental findings that can be expected in all cancer patients regardless of thrombotic status. Demographics, comorbidities, and stroke severity (for Groups 1 and 2 only) will be recorded on admission using a structured form. Study patients will undergo three facets of testing: 1) Transcranial Doppler (TCD) microemboli detection; 2) hematological biomarker testing; 3) peripheral blood leukocyte RNA gene expression analysis.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Hematological biomarker levels

时间窗: At enrollment

Hematological testing will consist of a single peripheral blood draw at 96 hours (+/-24 hours). Several factors will be evaluated, including markers of coagulation (thrombin-antithrombin complex, D-dimer), platelet function (P-selectin), and endothelial integrity (sICAM-1, sVCAM-1, thrombomodulin).

次要结局

  • Peripheral leukocyte RNA gene expression profiles(At enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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