UMIN-CTR Clinical Trial

Basic information
Public title	Diagnosis of toxoplasmosis by polymerase chain reaction
Acronym	Diagnosis of toxoplasmosis by polymerase chain reaction
Scientific Title	Diagnosis of toxoplasmosis by polymerase chain reaction
Scientific Title:Acronym	Diagnosis of toxoplasmosis by polymerase chain reaction
Region	Japan

Condition
Condition	Toxoplasmosis
Classification by specialty	Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To provide the results of PCR test for Toxoplasma gondii-DNA by using the clinical samples obtained from patients suspicious of or at high risk for developing toxoplasmosis. To establish the universally available diagnostic kit of quantitative PCR of toxoplasmosis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Results of PCR test for Toxoplasma gondii-DNA by using the clinical samples obtained from patients suspicious of or at high risk for developing toxoplasmosis
Key secondary outcomes

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients suspicious of developing toxoplasmosis in medical institutes in Japan 2) Patients at high risk of developing toxoplasmosis in medical institutes in Japan
Key exclusion criteria	1) Inability to obtain informed consent from the patient or relatives 2) Inability to obtain appropriate clinical samples
Target sample size	750

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Mikita
Organization	Keio University School of Medicine
Division name	Department of Infectious Diseases
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	0333531211
Email	tmori@a3.keio.jp

Public contact
Name of contact person	1st name Kei Middle name Last name Mikita
Organization	Keio University School of Medicine
Division name	Department of Infectious Diseases
Zip code	1608582
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL	0333531211
Homepage URL
Email	keimikita@keio.jp

Sponsor
Institute	Keio University School of Medicine
Institute
Department

Funding Source
Organization	MEDICAL & BIOLOGICAL LABORATORIES CO., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Ethical Committe of Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
Tel	0333531211
Email	med-rinri-jimu@adst.keio.ac.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

Other administrative information
Date of disclosure of the study information	2019 Year 11 Month 29 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	2019 Year 08 Month 27 Day
Date of IRB	2019 Year 11 Month 25 Day
Anticipated trial start date	2019 Year 12 Month 10 Day
Last follow-up date	2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	To provide the results of PCR of Toxoplasma gondii DNA by using the clinical samples obtained from patients suspicious of or at high risk for developing toxoplasmosis.

Management information
Registered date	2019 Year 11 Month 28 Day
Last modified on	2021 Year 05 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044136