UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047817 |
|---|---|
| Receipt number | R000054516 |
| Scientific Title | Acceleration of clinical tests, including molecular testing of infectious diseases and social implementation research of mobile laboratories and smart laboratories |
| Date of disclosure of the study information | 2022/05/28 |
| Last modified on | 2023/11/21 14:16:11 |
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Basic information
Public title
Acceleration of clinical tests including molecular testing of infectious diseases and social implementation research of mobile laboratories and smart laboratories
Acronym
Social implementation research of mobile laboratories and smart laboratories
Scientific Title
Acceleration of clinical tests, including molecular testing of infectious diseases and social implementation research of mobile laboratories and smart laboratories
Scientific Title:Acronym
Social implementation research of mobile laboratories and smart laboratories
Region
| Japan |
Condition
Condition
Infectious diseases including COVID-19
Classification by specialty
| Infectious disease | Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reduction of turn-round-time of clinical laboratory testing
Basic objectives2
Others
Basic objectives -Others
Validation of clinical laboratory
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Realization of rapid reporting (time from inspection request to report of results within 120 minutes)
Key secondary outcomes
Concordance rates in comparison to the results measured at the conventional measurement location as a reference
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
Consent to participate in this study was obtained in writing or verbally from the patient or their substitute.
Residual specimens of clinical laboratory specimens used in daily practice, or residual specimens collected for other research purposes.
Key exclusion criteria
We excluded the following patients
Patients who requested to withdraw after giving their consent for the clinical performance test.
Regarding the secondary use of samples used in other studies, if there an individual requested the refusal of the sample for secondary use, the sample will be excluded from the target.
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Hiromichi |
| Middle name | |
| Last name | Suzuki |
Organization
University of Tsukuba Hospital
Division name
Department of Infectious Diseases
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki Japan
TEL
029-853-3562
hsuzuki@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Hiromichi |
| Middle name | |
| Last name | Suzuki |
Organization
University of Tsukuba Hospital
Division name
Department of Infectious Diseases
Zip code
305-8576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki Japan
TEL
029-853-3562
Homepage URL
https://www.s.hosp.tsukuba.ac.jp/t-credo/rinsho/jimukyoku/pubpdf/R03-276.pdf
hsuzuki@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba Hospital
Institute
Department
Personal name
Funding Source
Organization
LSI medience
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
Tsukuba Clinical Research & Development Organization
Address
2-1-14 Amakubo, Tsukuba, Ibaraki Japan
Tel
029-853-3914
t-credo.adm@un.tsukuba.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
筑波大学附属病院（茨城県）、LSIメディエンス（東京都）、つくば i-Laboratory 有限責任事業組合（茨城県）、筑波メディカルセンター病院（茨城県）
University of Tsukuba Hospital(Ibaraki), LSI medience (TOKYO), Tsukuba i-Laboratory(Ibaraki), Tsukuba Medical Center Hospital (Ibaraki)
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 28 | 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
| 2022 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 02 | Month | 09 | Day |
Anticipated trial start date
| 2022 | Year | 02 | Month | 09 | Day |
Last follow-up date
| 2026 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 05 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054516
