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Mechanisms of Ischemic Stroke in Cancer Patients (MOST-CA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02604667
Recruitment Status : Suspended (Study paused due to COVID-19 and will resume based on guidance of public health authorities. This is not a suspension of IRB approval.)
First Posted : November 13, 2015
Last Update Posted : April 24, 2020
Sponsor:
Collaborators:
University of California, Davis
Memorial Sloan Kettering Cancer Center
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Stroke Cancer Other: Blood tests Other: Transcranial Doppler Microemboli Detection Study

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.

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Study Type : Observational
Estimated Enrollment : 165 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Mechanisms of Ischemic Stroke in Cancer Patients
Study Start Date : November 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Group/Cohort Intervention/treatment
Group 1: Cancer and Stroke
Patients with active solid tumor cancer and acute ischemic stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.
Other: Blood tests

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.


Other: Transcranial Doppler Microemboli Detection Study
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.

Group 2: Stroke and No Cancer
Patients with acute ischemic stroke and no cancer. Will undergo blood tests and transcranial Doppler microemboli detection study.
Other: Blood tests

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.


Other: Transcranial Doppler Microemboli Detection Study
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.

Group 3: Cancer and No Stroke
Patients with active solid tumor cancer and no stroke. Will undergo blood tests and transcranial Doppler microemboli detection study.
Other: Blood tests

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.


Other: Transcranial Doppler Microemboli Detection Study
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.




Primary Outcome Measures :
  1. Hematological biomarker levels [ Time Frame: 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 :
  1. Peripheral leukocyte RNA gene expression profiles [ Time Frame: 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.


Other Outcome Measures:
  1. Transcranial Doppler microemboli rates [ Time Frame: At enrollment ]
    With TCD studies, both middle cerebral arteries will be insonated for 30 minutes using a fixed headset. An experienced technologist will review the recording to ensure accurate characterization of all signals and a vascular neurologist with expertise in neurosonology will determine the rate and laterality of the microemboli. TCD microemboli in bilateral vascular distributions indicates a central embolic source.


Biospecimen Retention:   Samples Without DNA
Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study 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.
Criteria

Inclusion Criteria

  • 18 years of age or older
  • Active solid tumor cancer (for Groups 1 and 3 only)
  • MRI confirmed acute ischemic stroke (for Groups 1 and 2 only)
  • Available for blood draw at 96 hours (+/- 24 hours) from last known well time (for Groups 1 and 2 only) or within 2 weeks of enrollment (for Group 3)
  • Available for TCD within 2 weeks of enrollment

Exclusion Criteria

  • Primary brain tumor or hematological cancer
  • Treatment with intravenous or intraarterial thrombolysis or mechanical embolectomy
  • Platelets < 50,000/mm3
  • Hemodialysis within 14 days
  • Active pregnancy
  • Infection within 14 days per Infectious Diseases Society of America (IDSA) criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02604667


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
University of California, Davis
Memorial Sloan Kettering Cancer Center
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Babak Navi, MD, MS Weill Medical College of Cornell University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT02604667    
Other Study ID Numbers: 1411015653
K23NS091395 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Weill Medical College of Cornell University:
Biomarkers
Mechanisms
Transcranial Doppler
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases