UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043473 |
|---|---|
| Receipt number | R000049620 |
| Scientific Title | Ischemic Stroke in Patients with Cancer and Neoplasia (SCAN) study: a multicenter prospective observational study |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/03/01 00:42:51 |
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Basic information
Public title
Ischemic Stroke in Patients with Cancer and Neoplasia (SCAN) study: a multicenter prospective observational study
Acronym
SCAN study
Scientific Title
Ischemic Stroke in Patients with Cancer and Neoplasia (SCAN) study: a multicenter prospective observational study
Scientific Title:Acronym
SCAN study
Region
| Japan |
Condition
Condition
Ischemic stroke
Classification by specialty
| Cardiology | Neurology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical features of ischemic stroke associated with malignant tumors and neoplasia.
Basic objectives2
Others
Basic objectives -Others
To clarify stroke recurrence and mortality associated with malignant tumors and neoplasia.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Recurrent stroke and all-cause mortality up to 1 year after stroke onset
Key secondary outcomes
1. Incidence and recurrence of systemic thromboembolism up to 1 year after stroke onset
2. mRS at 90 days after ischemic stroke
3. Incidence of serious adverse events up to 1 year after the onset of ischemic stroke
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who are 20 years old or older at the time of obtaining consent
2) Patients who have been hospitalized within 14 days of the onset of ischemic stroke (or last attack in the case of transient ischemic attack)
3) Patients who have been treated or untreated for tumor within 5 years
Key exclusion criteria
1) Pregnant women, patients who may be pregnant, and lactating patients
2) Other patients who, at the discretion of the research physician, are considered inappropriate for enrollment in this study.
Target sample size
750
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Sakaguchi |
Organization
Osaka University
Division name
Neurology
Zip code
5650871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3571
sakaguti@gh.opho.jp
Public contact
Name of contact person
| 1st name | Yasufumi |
| Middle name | |
| Last name | Gon |
Organization
Osaka University
Division name
Neurology
Zip code
5650871
Address
2-2, Yamada-oka, Suita, Osaka
TEL
06-6879-3571
Homepage URL
gon@neurol.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Neurology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka University Clinical Research Review Committee
Address
2-2, Yamada-oka, Suita, Osaka, 565-0871, Japan
Tel
06-6210-8296
rinri@hp-crc.med.osaka-u.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
大阪大学医学部附属病院（大阪府），JCHO星ヶ丘医療センター（大阪府），国立病院機構大阪医療センター（大阪府），国立病院機構大阪南医療センター（大阪府），大阪労災病院（大阪府），淀川キリスト教病院（大阪府），神戸市立医療センター中央市民病院（兵庫県），国立循環器病研究センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | 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
151
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 25 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients enrolled in the study will be followed up for recurrent stroke or death up to 1 year. In addition, symptoms and test results at the time of hospitalization will be collected to clarify the clinical characteristics of cancer and ischemic stroke.
Management information
Registered date
| 2021 | Year | 03 | Month | 01 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049620
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
