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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000046173
Receipt No. R000052702
Scientific Title Epidemiology Study on the Attributable Fraction of Tick-Borne Encephalitis Virus (TBEV) [and bacteria belonging to genospecies of the Borrelia burgdorferi sensu lato group] as the causative agent in patients with CNS disease of unknown infectious aetiology in Japan
Date of disclosure of the study information 2021/11/25
Last modified on 2021/11/25

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Basic information
Public title Epidemiology Study on the Attributable Fraction of Tick-Borne Encephalitis Virus (TBEV) [and bacteria belonging to genospecies of the Borrelia burgdorferi sensu lato group] as the causative agent in patients with CNS disease of unknown infectious aetiology in Japan
Acronym A study to determine whether tick-borne encephalitis (TBE) or Lyme disease is the cause of infectious central nervous system diseases of unknown origin previously diagnosed in Japan.
Scientific Title Epidemiology Study on the Attributable Fraction of Tick-Borne Encephalitis Virus (TBEV) [and bacteria belonging to genospecies of the Borrelia burgdorferi sensu lato group] as the causative agent in patients with CNS disease of unknown infectious aetiology in Japan
Scientific Title:Acronym Epidemiology Study on the Attributable Fraction of Tick-Borne Encephalitis Virus (TBEV) [and bacteria belonging to genospecies of the Borrelia burgdorferi sensu lato group] as the causative agent in patients with CNS disease of unknown infectious aetiology 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 To assess the attributable fraction of Tick-Borne Encephalitis Virus (TBEV) as the causative agent in enrolled patients with CNS disease of unknown infectious aetiology.
Basic objectives2 Others
Basic objectives -Others Describe the demographics, clinical characteristics, and clinical outcomes of patients with TBE
Describe the risk factors such as occupation / leisure activities / 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 calculated attributable fraction to published data on the occurrence of CNS disease of known and unknown infectious aetiology in Japan
Trial characteristics_1 Others
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes The attributable fraction of Tick-Borne Encephalitis Virus (TBEV) as the causative agent in patients with CNS disease of unknown infectious aetiology
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 (100K persons)

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
12 months-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.Inpatient or outpatient (>=1 year of age) of participating hospital at time of diagnosis
Diagnosed with CNS disease of unknown infectious aetiology
2.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.
3.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 1000

Research contact person
Name of lead principal investigator
1st name Masaki
Middle name
Last name Takao
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
Email msktakaobrb@ncnp.go.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Konuki
Organization a2healthcare Corporation
Division name Clinical Development Division Clinical Research Department
Zip code 112-0002
Address 1-4-1,Koishikawa,Bunkyo-Ku,Tokyo 112-0002 JAPAN
TEL 03-3830-1075
Homepage URL
Email TBE_LB_epistudy_MO@a2healthcare.com

Sponsor
Institute National Center Hospital, National Center of Neurology and Psychiatry
Institute
Department

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
Email 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)

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 Preinitiation
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
2022 Year 12 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
2021 Year 11 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052702

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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