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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000022908
Receipt No. R000026369
Scientific Title Multicenter study of new diagnostic test kit for human toxocariasis
Date of disclosure of the study information 2016/07/01
Last modified on 2016/12/27

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Basic information
Public title Multicenter study of new diagnostic test kit for human toxocariasis
Acronym Development of diagnostic test kit for toxocariasis
Scientific Title Multicenter study of new diagnostic test kit for human toxocariasis
Scientific Title:Acronym Development of diagnostic test kit for toxocariasis
Region
Japan

Condition
Condition Toxocariasis
Classification by specialty
Infectious disease Ophthalmology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Clinical application of a new antibody detection kit for the suspected patients of toxocariasis. Samples for this purpose are serum, intraocular fluid, bronchoalveolar lavage fluid and cerebrospinal fluid.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Existence or non-existence of antibody against larval excretory-secretory antigen of Toxocara canis in serum or sample taken from suspected patients.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Collection of small amount of blood sample (5mL), bronchoalveoral lavage fluid (0.2 mL), or cerebrospinal fluid (0.2 mL) from clinically suspected patients with visceral toxocariasis. Collection of small amount of intraocural fluid (0.1 mL) from clinically suspected patients with ocular toxocariasis.
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 are clinically diagnosed with toxocariasis.
2) Person from whom written informed consent could be obtained.
Key exclusion criteria 1) Person who do not agree the participation in this study.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nobuaki Akao
Organization Tokyo Medical and Dental University
Division name Environmental Parasitology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5192
Email ocha.vip@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Akao
Organization Tokyo Medical and Dental University
Division name Environmental Parasitology
Zip code
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5190
Homepage URL
Email ocha.vip@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Japan Science and Technology Agency
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 東京医科歯科大学病院(東京都)、奈良県立医科大学病院(奈良県)、北海道大学病院(北海道)、東北大学病院(宮城県)、山形大学病院(山形県)、獨協医科大学病院(栃木県)、群馬大学病院(群馬県)、東京医科大学病院(東京都)、杏林大学病院(東京都)、岐阜大学病院(岐阜県)、鳥取大学病院(鳥取県)、愛媛大学病院(愛媛県)、高知大学病院(高知県)、山口大学病院(山口県)、久留米大学病院(福岡県)、大分大学(大分県)、宮田眼科病院(宮崎県)

Other administrative information
Date of disclosure of the study information
2016 Year 07 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
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2016 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 06 Month 27 Day
Last modified on
2016 Year 12 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026369

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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