Mechanisms of Ischemic Stroke in Cancer Patients

Completed

• Conditions: Cancer; Stroke
• Interventions: Other: Blood tests; Other: Transcranial Doppler Microemboli Detection Study

• Registration Number: NCT02604667
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

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 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-11-11
• Study First Submitted QC: 2015-11-11
• Study First Posted: 2015-11-13
• Study Start: 2016-04-08
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1: Cancer and Stroke	Blood tests	Patients with active solid tumor cancer and acute ischemic stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.
Group 1: Cancer and Stroke	Transcranial Doppler Microemboli Detection Study	Patients with active solid tumor cancer and acute ischemic stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.
Group 3: Cancer and No Stroke	Blood tests	Patients with active solid tumor cancer and no stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.
Group 2: Stroke and No Cancer	Transcranial Doppler Microemboli Detection Study	Patients with acute ischemic stroke and no cancer. Will undergo blood tests and transcranial Doppler microemboli detection study.
Group 3: Cancer and No Stroke	Transcranial Doppler Microemboli Detection Study	Patients with active solid tumor cancer and no stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.
Group 2: Stroke and No Cancer	Blood tests	Patients with acute ischemic stroke and no cancer. Will undergo blood tests and transcranial Doppler microemboli detection study.

Primary Outcome Measures

Name	Time	Method
Hematological biomarker levels	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).

Secondary Outcome Measures

Name	Time	Method
Peripheral leukocyte RNA gene expression profiles	At enrollment	Blood specimens will be collected at the time of enrollment in PAXgene tubes which will be frozen and stored at the Weill Cornell CTSC Core laboratory and sent in batches to the UC Davis laboratory where processing of RNA gene expression will occur.

Trial Locations

Locations (2)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

New York-Presbyterian Hospital/Weill Cornell Medical Center; 🇺🇸 New York, New York, United States