UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053960 |
|---|---|
| Receipt number | R000061590 |
| Scientific Title | Research on the establishment of surveillance medicine by exploratory analysis of viral specimens and investigation of subclinical infections. (Prospective cross-sectional case series study) |
| Date of disclosure of the study information | 2024/03/26 |
| Last modified on | 2024/03/25 10:54:12 |
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Basic information
Public title
Research on the establishment of surveillance medicine by exploratory analysis of viral specimens and investigation of subclinical infections
Acronym
Research on the establishment of surveillance medicine by exploratory analysis of viral specimens and investigation of subclinical infections
Scientific Title
Research on the establishment of surveillance medicine by exploratory analysis of viral specimens and investigation of subclinical infections.
(Prospective cross-sectional case series study)
Scientific Title:Acronym
Prospective cross-sectional case series study
Region
| Japan |
Condition
Condition
Outpatients with fever and general outpatients
Classification by specialty
| Pneumology | Adult | Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study aims to analyze the occurrence and combined risk of infectious diseases among fever outpatients and general outpatient visitors. The analysis will be conducted through exploratory analysis using salivary omics and information analysis using a questionnaire survey. The goal is to understand the pathogenic mechanism and generate research seeds.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(1) Age, gender, smoking status, alcohol consumption, underlying disease, medications, physical examination (body temperature, blood pressure, pulse rate, respiratory rate, oxygen saturation (SpO2), etc.)
(2) Blood tests: blood count, CRP, AST, ALT, LDH, ALP, total bilirubin, creatinine, etc.
(3) Clinical information related to respiratory tract infection: route of infection, diagnostic method, date of onset, date of resolution of fever, symptoms, therapeutic drugs, type of respiratory care, number of vaccinations, adverse reaction information, or complications caused by respiratory tract infection, date of diagnosis, date of complete recovery, sequela, etc.
(4) Drug prescriptions and treatment records
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Saliva taken
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
Outpatients with fever and general outpatients
Key exclusion criteria
Those who cannot give their consent to participate
Target sample size
2500
Research contact person
Name of lead principal investigator
| 1st name | Eiryo |
| Middle name | |
| Last name | Kawakami |
Organization
Graduate School of Medicine
Division name
Artificial Intelligence Medicine
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
ai-med@chiba-u.jp
Public contact
Name of contact person
| 1st name | Eiryo |
| Middle name | |
| Last name | Kawakami |
Organization
Graduate School of Medicine
Division name
Artificial Intelligence Medicine
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
TEL
043-222-7171
Homepage URL
ai-med@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
JST
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Graduate School of Medicine Ethics Review Committee
Address
1-8-1, Inohana, Chuo-ku, Chiba-shi, Chiba
Tel
043-222-7171
inohana-rinri@chiba-u.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 | 03 | Month | 26 | 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
| 2024 | Year | 01 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 03 | Month | 25 | Day |
Last modified on
| 2024 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061590
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
