StrokeMOST-CANCT02604667
Mechanisms of Ischemic Stroke in Cancer Patients
An observational study of Stroke and Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Blood tests and Transcranial Doppler Microemboli Detection Study
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Apr 2016to 1 Sep 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
New York-Presbyterian Hospital/Weill Cornell Medical Center
New York, New York, 10065
About this study
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.
Read the 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.
- Being tested
- Blood tests, Transcranial Doppler Microemboli Detection Study
- Keywords
- Biomarkers, Mechanisms, Transcranial Doppler
- Medical subject headings
- Stroke, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testsOther
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.
Transcranial Doppler Microemboli Detection StudyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Blood tests; Other: 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. Receives: Other: Blood tests; Other: 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. Receives: Other: Blood tests; Other: Transcranial Doppler Microemboli Detection Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At enrollment
Secondary outcomes (1)
Peripheral leukocyte RNA gene expression profiles
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.
Measured: At enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study start8 Apr 2016
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Davis, Memorial Sloan Kettering Cancer Center, National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Babak Navi, MD, MS, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604667
- Sponsor's protocol ID
- 1411015653
- Other IDs
- K23NS091395
- Acronym
- MOST-CA
- Status last verified
- May 2021
- First submitted
- 11 Nov 2015
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 31510897
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms of Ischemic Stroke in Cancer Patients
- ClinicalTrials.gov ID
- NCT02604667
- Acronym / sponsor ID
- MOST-CA / 1411015653
- Keywords
- Biomarkers, Mechanisms, Transcranial Doppler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- University of California, Davis, Memorial Sloan Kettering Cancer Center, National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 8 Apr 2016 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cancer and Stroke | – | Other: Blood tests, Other: Transcranial Doppler Microemboli Detection StudyPatients 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 | – | Other: Blood tests, Other: Transcranial Doppler Microemboli Detection StudyPatients with acute ischemic stroke and no cancer. Will undergo blood tests and transcranial Doppler microemboli detection study. |
| Group 3: Cancer and No Stroke | – | Other: Blood tests, Other: Transcranial Doppler Microemboli Detection StudyPatients with active solid tumor cancer and no stroke. Will undergo blood tests and transcranial Doppler microemboli detection study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testsStudy 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 | Group 1: Cancer and Stroke, Group 2: Stroke and No Cancer, Group 3: Cancer and No Stroke |
| Transcranial Doppler Microemboli Detection StudyStudy 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. | Other | Group 1: Cancer and Stroke, Group 2: Stroke and No Cancer, Group 3: Cancer and No Stroke |
Primary outcome
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).
1 secondary outcome
Peripheral leukocyte RNA gene expression profiles
Time frame: At enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 31510897Navi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Babak Navi, MD, MS principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Cancer, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematological biomarker levels (time frame: At enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604667, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.