UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057851 |
|---|---|
| Receipt number | R000066105 |
| Scientific Title | A Comprehensive Study of Respiratory Infections in Preparation for the Next Pandemic |
| Date of disclosure of the study information | 2025/05/14 |
| Last modified on | 2025/05/13 11:46:28 |
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Basic information
Public title
A Comprehensive Study of Respiratory Infections in Preparation for the Next Pandemic
Acronym
A Comprehensive Study of Respiratory Infections in Preparation for the Next Pandemic
Scientific Title
A Comprehensive Study of Respiratory Infections in Preparation for the Next Pandemic
Scientific Title:Acronym
A Comprehensive Study of Respiratory Infections in Preparation for the Next Pandemic
Region
| Japan |
Condition
Condition
Respiratory infection
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Through whole genome sequencing, RNA sequencing, and pathogen genome analysis of patients with respiratory infections, we aim to comprehensively elucidate the mechanisms of respiratory infectious diseases with preparing for the next pandemic. This includes the analysis of host factors involved in infection and disease severity, pathogen virulence, host-pathogen interactions, and the development of a system for predicting disease severity.
Basic objectives2
Others
Basic objectives -Others
To identify and elucidate genes associated with respiratory infectious diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Genes associated with respiratory disease
Key secondary outcomes
Analysis of genetic polymorphisms through GWAS, and multi-omics analyses including whole-transcriptome RNA sequencing, methylation profiling, metabolomics, proteomics, and microbiome analysis. Functional analysis of disease susceptibility genes.
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
Patients diagnosed with or suspected of having a respiratory infection
Key exclusion criteria
never
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | Ho |
| Middle name | |
| Last name | Namkoong |
Organization
Keio University School of Medicine
Division name
Department of Infectious Diseases
Zip code
160-0016
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
hounamugun@keio.jp
Public contact
Name of contact person
| 1st name | Ho |
| Middle name | |
| Last name | Namkoong |
Organization
Keio University School of Medicine
Division name
Department of Infectious Diseases
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
hounamugun@keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Ho Namkoong
Funding Source
Organization
Japan Agency for Medical Research and Development(AMED)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
N/A
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
| 2025 | Year | 05 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 08 | Day |
Last follow-up date
| 2034 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is a cross-sectional study.
It aims to elucidate the pathophysiology of respiratory infections by integrating patient information obtained from medical records and questionnaires including age, sex, blood test results, imaging data, pathogen information, treatment details, and self-reported symptoms?with data derived from specimens collected at participating institutions (such as blood, nasopharyngeal swabs, sputum, and lung/airway samples obtained through bronchoscopy). These specimens will be used to extract DNA, RNA, serum, plasma, peripheral blood mononuclear cells (PBMCs), and pathogens for analysis.
All samples will be anonymized and strictly managed at each participating institution.
Analyses will be conducted at Keio University, other participating research institutions, and commissioned analytical service providers. These analyses include whole-genome sequencing, RNA sequencing, SNP array analysis, methylation analysis, metabolomics, proteomics, and other omics approaches, as well as pathogen genome analysis.
The study will perform genome-wide association studies (GWAS) for genetic polymorphism analysis, whole-transcriptome RNA sequencing, methylation analysis, metabolomics, proteomics, microbiome analysis, and functional analysis of disease susceptibility genes.
Management information
Registered date
| 2025 | Year | 05 | Month | 13 | Day |
Last modified on
| 2025 | Year | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066105
