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 2023/12/07 10:46:30

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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 prevalence of risk factors such as occupation/leisure activities/food exposures/travel history/history of tick bite/TBE vaccination status for patients with CNS disease of unknown suspected infectious aetiology (prospectively enrolled subjects)
Estimate the incidence of TBE in Japan by applying the proportion of cases of CNS disease of unknown suspected infectious etiology to published data on the occurrence of CNS disease ofunknown 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 (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

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

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 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

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)、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

Open public 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

2023 Year 12 Month 07 Day



Link to view the page

Value
https://center6.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