UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter study of new diagnostic test kit for human toxocariasis
Title of the study (Brief title)	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	Nobuaki Akao
Organization	Tokyo Medical and Dental University
Division name	Environmental Parasitology
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	Nobuaki Akao
Organization	Tokyo Medical and Dental University
Division name	Environmental Parasitology
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 06 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000026369