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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000035754 |
Receipt No. | R000040682 |
Official scientific title of the study | Development of a minimally invasive, ultra-sensitive rapid diagnosis kit for influenza virus |
Date of disclosure of the study information | 2019/02/08 |
Last modified on | 2019/02/03 |
Basic information | ||
Official scientific title of the study | Development of a minimally invasive, ultra-sensitive rapid diagnosis kit for influenza virus | |
Title of the study (Brief title) | Development of rapid diagnosis kit for influenza virus | |
Region |
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Condition | ||||
Condition | Influenza virus infection | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Investigate the influenza virus amount in various specimens at onset |
Basic objectives2 | Others |
Basic objectives -Others | To clarify the relationship between influenza virus amount before onset and onset |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Influenza virus amount at onset |
Key secondary outcomes | Influenza virus amount before onset |
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 | |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who have fever up and/ or respiratory illness, and their families. | |||
Key exclusion criteria | none | |||
Target sample size | 400 |
Research contact person | |
Name of lead principal investigator | Kazuhito Tabata |
Organization | School of Engineering, The University of Tokyo |
Division name | Noji Laboratory |
Address | 6A09, Faculty of Engineering Building 3, Hongo 7-3-1, Bunkyo-ku, Tokyo, JAPAN |
TEL | 03-5841-7252 |
kazuhito@nojilab.t.u-tokyo.ac.jp |
Public contact | |
Name of contact person | Kazuhito Tabata |
Organization | School of Engineering, The University of Tokyo |
Division name | Noji laboratory |
Address | 6A09, Faculty of Engineering Building 3, Hongo 7-3-1, Bunkyo-ku, Tokyo, JAPAN |
TEL | 03-5841-7252 |
Homepage URL | |
kazuhito@nojilab.t.u-tokyo.ac.jp |
Sponsor | |
Institute | The University of Tokyo |
Institute | |
Department |
Funding Source | |
Organization | Japan Science and Technology Agency |
Organization | |
Division | |
Category of Funding Organization | Non profit foundation |
Nationality of Funding Organization |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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Progress | |||||||
Recruitment status | Preinitiation | ||||||
Date of protocol fixation |
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Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
URL releasing results | |
Results | |
Other related information | Multicenter study.
For patients with fever or respiratory symptoms and their families, samples are taken from nasal cavities and pharynx, and the amount of virus is measured. By investigating the amount of virus in various specimens and the progress of symptoms of the subjects, relationships between symptoms and the amount of virus are clarified. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040682 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |