UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038716 |
|---|---|
| Receipt number | R000044136 |
| Scientific Title | Diagnosis of toxoplasmosis by polymerase chain reaction |
| Date of disclosure of the study information | 2019/11/29 |
| Last modified on | 2021/05/29 21:11:59 |
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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 | 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
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
keimikita@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044136
