Mechanisms of Ischemic Stroke in Cancer Patients "MOST-CA"

Recruiting

Phase N/A Results N/A

Trial Description

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.

Detailed Description

This will be a prospective cross-sectional study to examine the unique mechanisms of ischemic stroke in cancer patients. Enrollment will occur at the New York-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 +/- 6 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.

Conditions

Interventions

  • Blood tests Other
    Intervention Desc: Study participants will undergo a single, peripheral blood draw. Blood specimens will be used to perform hematological biomarker testing and leukocyte RNA gene expression analysis. Hematological biomarker testing will be performed to better elucidate the mechanisms of ischemic stroke in cancer patients and will include markers of coagulation, platelet function, and endothelial integrity. This analysis will occur at MSKCC. Leukocyte RNA gene expression analysis will be performed to evaluate whether patients with cancer and stroke more often have cardioembolic mechanisms than patients with stroke and no cancer. This analysis will occur at the University of California, Davis where investigators have previously shown that differential RNA expression patterns can predict stroke subtypes.
    ARM 1: Kind: Experimental
    Label: Group 1: Cancer and Stroke
    Description: Patients with active solid tumor cancer and acute ischemic stroke.
    ARM 2: Kind: Experimental
    Label: Group 2: Stroke and No Cancer
    Description: Patients with acute ischemic stroke and no cancer.
    ARM 3: Kind: Experimental
    Label: Group 3: Cancer and No Stroke
    Description: Patients with active solid tumor cancer and no stroke.
  • Transcranial Doppler Microemboli Detection Study Other
    Intervention Desc: Study participants will undergo a single Transcranial Doppler Microemboli Detection Study at NYPH/WCMC or MSKCC within two weeks of enrollment. Both middle cerebral arteries will be insonated for 30 minutes by a trained technician or stroke neurologist certified in neurosonology using a fixed headset to assess for the rate and laterality of microemboli.
    ARM 1: Kind: Experimental
    Label: Group 1: Cancer and Stroke
    Description: Patients with active solid tumor cancer and acute ischemic stroke.
    ARM 2: Kind: Experimental
    Label: Group 2: Stroke and No Cancer
    Description: Patients with acute ischemic stroke and no cancer.
    ARM 3: Kind: Experimental
    Label: Group 3: Cancer and No Stroke
    Description: Patients with active solid tumor cancer and no stroke.

Trial Design

  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

We plan to enroll three groups of 55 patients each. Group 1 will consist of patients with acute ischemic stroke and active solid tumor cancer, Group 2 will include patients with acute ischemic stroke and no cancer, and Group 3 will include patients with active solid tumor cancer and no stroke.

Outcomes

Type Measure Time Frame Safety Issue
Primary Hematological biomarker levels At enrollment No
Primary Peripheral leukocyte RNA gene expression profiles At enrollment No
Primary Transcranial Doppler microemboli rates Within 2 weeks of enrollment No

Biospecimen Retention:Samples Without DNA - Blood samples

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