UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046173 |
|---|---|
| Receipt number | R000052702 |
| Scientific Title | Study to determine the proportion of cases of CNS disease of unknown suspected infectious aetiology caused by Tick-Borne Encephalitis Virus (TBEV) [and bacteria belonging to genospecies of the Borrelia burgdorferi sensu lato group] in Japan |
| Date of disclosure of the study information | 2021/11/25 |
| Last modified on | 2025/01/24 14:10:52 |
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Basic information
Public title
Study to determine the proportion of cases of CNS disease of unknown suspected infectious aetiology caused by Tick-Borne Encephalitis Virus (TBEV) [and bacteria belonging to genospecies of the Borrelia burgdorferi sensu lato group] in Japan
Acronym
The proportion of CNS disease of unknown suspected infectious aetiology caused by the bacterium Borrelia burgdorferi will be an exploratory objective.
Scientific Title
Study to determine the proportion of cases of CNS disease of unknown suspected infectious aetiology caused by Tick-Borne Encephalitis Virus (TBEV) [and bacteria belonging to genospecies of the Borrelia burgdorferi sensu lato group] in Japan
Scientific Title:Acronym
Study to determine the proportion of cases of CNS disease of unknown suspected infectious aetiology caused by Tick-Borne Encephalitis Virus (TBEV) [and bacteria belonging to genospecies of the Borrelia burgdorferi sensu lato group] in Japan
Region
| Japan |
Condition
Condition
CNS disease of unknown infectious aetiology
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Determine the proportion of cases of CNS disease of unknown suspected infectious aetiology caused by Tick-Borne Encephalitis Virus (TBEV)
Basic objectives2
Others
Basic objectives -Others
Describe the demographic and clinical characteristics and clinical outcomes of patients with laboratory confirmation of TBE in study
Describe the risk factors such as occupation / leisure activities / food exposures/ travel history / history of tick bite for patients with CNS disease of unknown infectious aetiology
Estimate the incidence of TBE in Japan by applying the proportion of CNS disease of unknown suspected infectious aetiology caused by TBEV to published data on the occurrence of CNS disease of unknown suspected infectious aetiology in Japan
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The proportion of cases of CNS disease of unknown suspected infectious aetiology caused by Tick-Borne Encephalitis Virus (TBEV)
Key secondary outcomes
Demographics, clinical characteristics, and clinical outcomes of patients diagnosed with TBE
Proportions of patients with risk factors per capita (100K persons)
The annual incidence rate of TBE in Japan per capita (TBE cases per 100K persons per year)
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
| 1 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Inpatient or outpatient (more than 1 year of age) of participating hospital at time of diagnosis
2.Diagnosed with CNS disease of unknown infectious aetiology (See Appendix 3 for definition of CNS of unknown infectious aetiology)
3.In the retrospective part of the study, subjects will be enrolled in this study according to the opt-out process, after the ethical committee has approved this process.
In the prospective part of the study, evidence of a signed and dated informed consent form indicating that the patient or their legally authorized representative(s) have been informed of all pertinent aspects of the study and agree to participate.
4.In the retrospective part of the study, availability of residual CSF and/or sera sample(s) collected as part of standard of care. In the prospective part of the study, agreement to blood collection.
Key exclusion criteria
1.Previous enrolment in this study for the same episode of the disease
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Ohira |
Organization
National Center Hospital, National Center of Neurology and Psychiatry
Division name
Department of Clinical Laboratory
Zip code
187-0031
Address
4-1-1Ogawahigashi-cho, Kodaira-shi, Tokyo
TEL
042-341-2711
msktakaobrb@ncnp.go.jp
Public contact
Name of contact person
| 1st name | Hajime |
| Middle name | |
| Last name | Kanazaki |
Organization
a2healthcare Corporation
Division name
Clinical Development Division Clinical Development Department 4
Zip code
112-0002
Address
1-4-1,Koishikawa,Bunkyo-Ku,Tokyo 112-0002 JAPAN
TEL
03-3830-1075
Homepage URL
TBE_LB_epistudy_MO@a2healthcare.com
Sponsor or person
Institute
National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department
Personal name
Masayuki Ohira
Funding Source
Organization
Pfizer Inc (US)
Pfizer Japan
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan, US
Other related organizations
Co-sponsor
Nagasaki University
Yamaguchi University
Pfizer Orth Serology Testing Laboratory
Pfizer Inc(US)
Pfizer Japan
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center of Neurology and Psychiatry Clinical Research Review Board
Address
4-1-1Ogawahigashi-cho, Kodaira-shi, Tokyo
Tel
042-341-2712
rinri-jimu@ncnp.go.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
国立・神経医療センター（東京都）、大分県立病院（大分県）、天理よろづ相談所病院（奈良県）、岡山大学病院（岡山県）、倉敷中央病院（岡山県）、独立行政法人国立病院機構 (以降独法) 別府医療センター（大分県）、自治医科大学附属病院（栃木県）、奈良県立医科大学附属病院（奈良県）、福井大学医学部附属病医院（福井県）、日本大学医学部附属板橋病院（東京都）、青森県立中央病院（青森県）、独法 信州上田医療センター（長野県）、北海道大学病院（北海道）、独法 旭川医療センター（北海道）、一般財団法人脳神経疾患研究所附属総合南東北病院（福島県）、市立函館病院（北海道）、山口大学医学部附属病院（山口県）、総合病院土浦協同病院（茨城県）、旭川赤十字病院（北海道）、大阪赤十字病院（大阪）、地方独立行政法人神戸市民病院機構神戸市立医療センター中央市民病院（兵庫県）、独法 埼玉病院（埼玉県）、公立昭和病院（東京都）、地方独立行政法人大阪市民病院機構 大阪市立総合医療センター（大阪府）、地方独立行政法人東京都立病院機構東京都立神経病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 25 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 29 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective: Schedule of Study Procedures/Assessments
Screening/medical record review to confirm eligibility
Assign anonymized subject identification number
Medical record review to collect data as available: demographics, location of residence, occupation, details of diagnosis of CNS disease of unknown infectious aetiology, history related to tick-borne disease including recent travel, tick bite, flavivirus/tick-borne disease, and vaccination against TBE, Yellow Fever, West Nile Virus, and Japanese encephalitisa
Scavenge residual standard of care (SOC) sera and/or cerebrospinal fluid (CSF) as available
Prospective: Schedule of Study Procedures/Assessments
Screening/medical record review to confirm eligibility
Informed consent/assent
Assign anonymized subject identification number
Collect demographics and location of residence
Patient (or legally authorized representative) interview, including signs/symptoms of current illness, occupational/leisure risk factors, travel history
Blood draw and post-blood draw observation for at least 10 minutes
Scavenge residual standard of care (SOC) cerebrospinal fluid (CSF) if available
Medical chart review to collect details of current illness, history related to tick-borne disease including tick bite, flavivirus/tick-borne disease, and vaccination against TBE, Yellow Fever, West Nile Virus, and Japanese encephalitis
Disposition
Management information
Registered date
| 2021 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052702
