UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053033 |
|---|---|
| Receipt number | R000060501 |
| Scientific Title | Clinical research contributing to infectious disease nucleic acid detection and diagnosis using digital detection methods |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2023/12/08 12:35:15 |
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Basic information
Public title
Clinical research contributing to infectious disease nucleic acid detection and diagnosis using digital detection methods
Acronym
Clinical research contributing to infectious disease nucleic acid detection and diagnosis using digital detection methods
Scientific Title
Clinical research contributing to infectious disease nucleic acid detection and diagnosis using digital detection methods
Scientific Title:Acronym
Clinical research contributing to infectious disease nucleic acid detection and diagnosis using digital detection methods
Region
| Japan |
Condition
Condition
infectious disease
Classification by specialty
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Nucleic acid detection method development
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Positive consistency rate, negative consistency rate
Key secondary outcomes
Obtaining epidemiological information
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are deemed suitable for participation in this study by a doctor at the research institution
Patients who have given informed consent
Key exclusion criteria
Patients who have requested non-participation in this study using the published opt-out document
Patients who have requested non-participation using a consent withdrawal form
Patients deemed unsuitable by the clinical research physician
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Takahashi |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Infection Contorol and Laboratory Medicine
Zip code
060-8543
Address
Minami 1-jo Nishi 16-chome, Chuo-ku, Sapporo
TEL
011-611-2111
stakahas@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | KOGO |
Organization
RIKEN
Division name
RIKEN Cluster for Pioneering Research
Zip code
351-0198
Address
2-1 Hirosawa, Wako, Saitama
TEL
048-462-1111
Homepage URL
yasushi.kogo@riken.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Sapporo Medical University School of Medicine
Address
Minami 1-jo Nishi 17-chome, Chuo-ku, Sapporo
Tel
0116112111
ji-rskk@sapmed.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
| 2024 | Year | 01 | Month | 01 | 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
| 2023 | Year | 11 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
,
Management information
Registered date
| 2023 | Year | 12 | Month | 08 | Day |
Last modified on
| 2023 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060501
