Mechanisms of Ischemic Stroke in Cancer Patients
MOST-CA
2 other identifiers
observational
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2016
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2015
CompletedFirst Posted
Study publicly available on registry
November 13, 2015
CompletedStudy Start
First participant enrolled
April 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMay 5, 2021
May 1, 2021
4.4 years
November 11, 2015
May 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hematological biomarker levels
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).
At enrollment
Secondary Outcomes (1)
Peripheral leukocyte RNA gene expression profiles
At enrollment
Other Outcomes (1)
Transcranial Doppler microemboli rates
At enrollment
Study Arms (3)
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.
Group 2: Stroke and No Cancer
Patients with acute ischemic stroke and no cancer. Will undergo blood tests and transcranial Doppler microemboli detection study.
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.
Interventions
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.
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.
Eligibility Criteria
We plan to enroll three groups of 50 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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065, United States
Related Publications (1)
Navi BB, Mathias R, Sherman CP, Wolfe J, Kamel H, Tagawa ST, Saxena A, Ocean AJ, Iadecola C, DeAngelis LM, Elkind MSV, Hull H, Jickling GC, Sharp FR, Ander BP, Stamova B. Cancer-Related Ischemic Stroke Has a Distinct Blood mRNA Expression Profile. Stroke. 2019 Nov;50(11):3259-3264. doi: 10.1161/STROKEAHA.119.026143. Epub 2019 Sep 12.
PMID: 31510897DERIVED
Biospecimen
Blood samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Babak Navi, MD, MS
Weill Medical College of Cornell University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2015
First Posted
November 13, 2015
Study Start
April 8, 2016
Primary Completion
September 1, 2020
Study Completion
September 1, 2020
Last Updated
May 5, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share