UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048954 |
|---|---|
| Receipt number | R000055778 |
| Scientific Title | CLECSTRO Study (LM22-01 Clinical performance Study) |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/10/18 18:15:32 |
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Basic information
Public title
sCLEC-2 in Stroke Study
Acronym
sCLEC-2 in STROKE STUDY
Scientific Title
CLECSTRO Study (LM22-01 Clinical performance Study)
Scientific Title:Acronym
CLECSTRO Study
Region
| Japan |
Condition
Condition
Acute ischemic stroke and transient ischemic attack
Classification by specialty
| Neurology | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the clinical significance of sCLEC-2 in assisting in the diagnosis, judging the effect of antithrombotic therapy, classifying disease subtypes, and predicting the outcome of acute ischemic cerebrovascular disease.
Basic objectives2
Others
Basic objectives -Others
1. Diagnosis of Acute Ischemic Stroke and TIA
The ischemic stroke group and TIA group will be compared with the control group to evaluate whether the sCLEC-2 level contributes to the improvement of diagnostic accuracy.
2. Evaluation of Antithrombotic Therapy
The post-treatment sCLEC-2 levels in patients with acute ischemic cerebrovascular disorders will be compared between patients without worsening/recurrence (effective treatment group) and those with worsening/recurrence during treatment (ineffective treatment group).
3. Comparison of sCLEC-2 /D-dimer ratio between cardiogenic and non-cardiogenic etiologies
The ischemic stroke group and TIA group will be classified into cardiogenic and non-cardiogenic etiologies based on the TOAST classification to evaluate the contribution of the sCLEC-2/ D-dimer to the subtype classification.
4. Correlation of sCLEC-2 levels on admission with outcome of ischemic stroke and TIA at 3 months
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Soluble C-type lectin-like receptor 2 level for the difference between patients (ischemic stroke or transient ischemic attack) and controls (neurological patients to require differentiation from ischemic stroke or transient ischemic attack)
Key secondary outcomes
Soluble C-type lectin-like receptor 2 level for the (1) correlation with severity of stroke,(2) correlation with size of infarct, (3) correlation with ABCD2 score in transient ischemic attack, (4) relationship between treatment effect and worsening or recurrence,(5) in the ratio to D-dimer between cardiogenic and non-cardiogenic etiology, (6) difference between TOAST subtypes of ischemic stroke, and (7) correlation with outcome(mRS and major vascular events) at 3 months
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who visited the research institution during the period from the date of permission of the head of the research institution to September 30, 2025
2) Inclusion criteria by group
-AIS group: patients diagnosed with ischemic stroke within 24 hours after onset and an mRS of 0-2 before the onset
-TIA group: patients diagnosed with TIA by two physicians based on the NINDS-III diagnostic criteria and within 7 days of attack (no evidence of acute infarction, and episodes of focal neurological dysfunction resolved within 24 hours)
-Control group: patients with suspected AIS or TIA but diagnosed with another disease by two physicians
Key exclusion criteria
1) Concomitant conditions that may affect platelets or blood coagulation, such as acute thrombosis of other organs, hematologic disorders, or pregnancy
2) Cerebral hemorrhage, subarachnoid hemorrhage, traumatic brain injury, other trauma, postoperative cases, and bleeding disorders
3) Severe infectious disease
4) Exclusion criteria by group
AIS and TIA groups: patients whose onset time is unknown except for those for whom the onset occurred during sleep
5) Patients who are deemed inappropriate for this study by a physician
6) Inadequate condition of the collected specimens
-Coagulation has occurred in a citrated blood collection tube
-Too little or too much blood sampling volume in citrated plasma
-Total bilirubin level of 10 mg/dL or more
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Katsue / Shinichiro |
| Middle name | |
| Last name | Suzuki-Inoue / Uchiyama |
Organization
University of Yamanashi / Sanno Medical Center and LSI Medience Co.
Division name
Department of Clinical and Laboratory Medicine / Center of Brain and Cerebral Vessels (Sanno Medical Center) Scientific Marketing Department (LSI Medience Co.)
Zip code
409-3898 Yamanashi / 107-0052 Sanno
Address
1110,Shimokato,Chuo-shi,Yamanashi, Japan (University of Yamanashi) / 8-5-35 Akasaka, Minato-ku, Tokyo, Japan (Sanno Medical Center, suchiyama@iuhw.ac.jp)
TEL
+81-55-273-1111(+81-3-3402-5581)
katsuei@yamanashi.ac.jp
Public contact
Name of contact person
| 1st name | Katsue |
| Middle name | |
| Last name | Suzuki-Inoue |
Organization
University of Yamanashi
Division name
Department of Clinical and Laboratory Medicine
Zip code
409-3898
Address
1110,Shimokato,Chuo-shi,Yamanashi, Japan
TEL
+81-55-273-1111
Homepage URL
katsuei@yamanashi.ac.jp
Sponsor or person
Institute
University of Yamanashi
Institute
Department
Personal name
Funding Source
Organization
LSI Medience Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Iwate Medical University,
Kyorin University Hospital,
Showa General Hospital,
Kyushu Medical Center,
Saiseikai Central Hospital,
Nippon Medical School Musashikosugi Hospital,
Mie Prefectural General Medical Center,
LSI Medience Co.
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
University of Yamanashi Faculty of Medicine Ethics Committee
Address
1110,Shimokato,Chuo-shi,Yamanashi,Japan
Tel
+81-55-273-9065
rec-med@yamanashi.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT05579405
Org. issuing International ID_1
ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
岩手医科大学病院（岩手県）／ Iwate Medical University Hospital
東京都済生会中央病院（東京都）／ Tokyo Saiseikai Central Hospital
杏林大学病院（東京都）／ Kyorin University Hospital
公立昭和病院（東京都）／ Showa General Hospital
日本医科大学武蔵小杉病院（神奈川県）／ Nippon Medical School Musashikosugi Hospital
山梨大学病院（山梨県）／ University of Yamanashi Hospital
三重県立総合医療センター(三重県)／ Mie Prefectural General Medical Center
九州医療センター（福岡県）／ Kyushu Medical Center
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | 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
Undecided
IPD sharing Plan description
Undecided
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 12 | Month | 31 | Day |
Other
Other related information
Currently, there is no marker that can easily evaluate platelet activation. sCLEC-2 has been developed as a platelet activation marker that can be used in routine clinical practice. In this study, we evaluate the clinical usefulness of sCLEC-2 as a marker of platelet activation in patients with ischemic stroke and TIA, in which platelet activation is one of the important etiologies.
Management information
Registered date
| 2022 | Year | 09 | Month | 16 | Day |
Last modified on
| 2023 | Year | 10 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055778
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