UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057739 |
|---|---|
| Receipt number | R000065978 |
| Scientific Title | The Endovascular Stroke thrombectomy for Patients with active Oncologic Illness aiming at Recovery registry |
| Date of disclosure of the study information | 2025/05/01 |
| Last modified on | 2025/04/29 17:16:57 |
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Basic information
Public title
The Endovascular Stroke thrombectomy for Patients with active Oncologic Illness aiming at Recovery registry
Acronym
ESPOIR registry
Scientific Title
The Endovascular Stroke thrombectomy for Patients with active Oncologic Illness aiming at Recovery registry
Scientific Title:Acronym
ESPOIR registry
Region
| Japan |
Condition
Condition
Acute ischemic stroke due to large vessel occlusion associated with active malignancy
Classification by specialty
| Medicine in general | Neurology | Neurosurgery |
| Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to:
1. Establish appropriate outcome measures to evaluate the effectiveness of endovascular reperfusion therapy in patients with acute ischemic stroke associated with active malignancy, and
2. Clarify the efficacy and safety of endovascular therapy compared to medical management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Primary Efficacy Endpoint: A composite outcome of either discharge to home within 90 days after stroke onset, or a mRS score of 0-2 or a return to the pre-stroke mRS score at 90 days after onset.
Primary Safety Endpoints: All-cause mortality within 90 days after stroke onset, symptomatic intracranial hemorrhage (sICH) within 7 days after onset.
Key secondary outcomes
Discharge to home within 90 days after onset.
At discharge and at 90 days after onset: mRS score, mRS 0-2, return to the pre-stroke mRS score, composite outcome of achieving mRS 0-2 or returning to the pre-stroke mRS score.
Initiation or resumption of active cancer treatment (surgical resection, chemotherapy, radiotherapy, or other therapies aimed at cure or life-prolongation) within 90 days after stroke onset.
Asymptomatic intracranial hemorrhage (ICH) or any ICH (classified according to the Heidelberg Bleeding Classification) within 7 days after onset.
Rate of successful reperfusion (defined as modified Thrombolysis in Cerebral Infarction [mTICI] grade 2b, 2c, or 3) and rate of complete reperfusion in the EVT group.
Subgroup analyses stratified by clinically relevant factors such as stroke subtype, cancer stage and others.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Adults aged 18 years or older.
(2) Patients who were hospitalized and treated at participating institutions between January 1, 2018, and December 31, 2024.
(3) Patients with acute ischemic stroke who were admitted within 24 hours from symptom onset or from last known well time, who also had active malignancy (including in-hospital stroke onset and patients diagnosed with active malignancy after stroke onset).
(4) Patients who developed ischemic stroke due to acute large vessel occlusion (common carotid artery [CCA], internal carotid artery [ICA], M1 or M2 segment of the middle cerebral artery [MCA], vertebral artery [VA], or basilar artery [BA]).
(5) Patients with a National Institutes of Health Stroke Scale (NIHSS) score of 6 or higher at onset.
(6) Patients with an Alberta Stroke Program Early CT Score (ASPECTS) of 3 or higher for anterior circulation occlusions, or a posterior circulation Acute Stroke Prognosis Early CT Score (pc-ASPECTS) of 6 or higher for posterior circulation occlusions, assessed by non-contrast CT or diffusion-weighted MRI (DWI).
Key exclusion criteria
(1) The patient or the legal representative expresses a refusal to participate.
(2) The attending physician determines that the patient is ineligible for enrollment in the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | MIKITO |
| Middle name | |
| Last name | HAYAKAWA |
Organization
University of Tsukuba Hospital
Division name
Department of Stroke and Cerebrovascular Diseases
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
0298533220
mikito-h@jc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | MIKITO |
| Middle name | |
| Last name | HAYAKAWA |
Organization
University of Tsukuba Hospital
Division name
Department of Stroke and Cerebrovascular Diseases
Zip code
305-8576
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
TEL
0298533220
Homepage URL
mikito-h@jc4.so-net.ne.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
The 41st Annual Meeting of the Japanese Society for Neuroendovascular Therapy (JSNET)
Division of Stroke Prevention and Treatment, Institute of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tsukuba Clinical Reserch & Development Organization
Address
2-1-1, Amakubo, Tsukuba, Ibaraki, Japan
Tel
0298537562
rinshokenkyu@un.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 03 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 26 | Day |
Last follow-up date
| 2025 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study period : From the date of approval by the institutional review board (IRB) until December 31, 2030.
Patient Enrollment Period : From the date of IRB approval until September 30, 2025.
Data collection period : From January 1, 2018 to December 31, 2024.
Management information
Registered date
| 2025 | Year | 04 | Month | 29 | Day |
Last modified on
| 2025 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065978
