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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038716
Receipt No. R000044136
Scientific Title Diagnosis of toxoplasmosis by polymerase chain reaction
Date of disclosure of the study information 2019/11/29
Last modified on 2019/11/28

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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 Takehiko
Middle name
Last name Mori
Organization Keio University School of Medicine
Division name Division of Hematology, Department of Medicine
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 Takehiko
Middle name
Last name Mori
Organization Keio University School of Medicine
Division name Division of Hematology, Department of Medicine
Zip code 1608582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL 0333531211
Homepage URL
Email tmori@a3.keio.jp

Sponsor
Institute Division of Hematology, Department of Medicine, 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 Preinitiation
Date of protocol fixation
2019 Year 08 Month 27 Day
Date of IRB
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
2019 Year 11 Month 28 Day


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

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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