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This study investigates the diversity of the respiratory virome in healthy individuals in Shanghai and its interaction with the host's baseline immune response. The respiratory virome plays a critical role in various diseases, but research on the respiratory virome in healthy individuals in China is limited. This prospective study will analyze the upper and lower respiratory virome and examine the effects of demographic factors such as age, gender, and geographic background. Additionally, a respiratory virome database will be established, and multi-omics approaches will be used to study immune response mechanisms in relation to virome diversity.
The study aims to provide comprehensive baseline data on the respiratory virome in healthy individuals in Shanghai. The primary goal is to investigate virome diversity in the upper and lower respiratory tracts and assess how demographic factors influence virome composition. Furthermore, the study will identify previously unknown viral sequences and explore their potential role in the immune system's interaction with the virome. Multi-omics approaches, including transcriptomics and proteomics, will be utilized to evaluate immune-related biomarkers and gene expression related to respiratory virome diversity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Young Healthy Volunteers Group | Age Range: 20-35 years Health Status: Participants in this group must be in good overall health, as determined by medical history, physical examination, and results of a routine health check-up within the past year. Body Mass Index (BMI): Must be between 19-26 kg/m² (inclusive), with a minimum weight of 50 kg for males and 45 kg for females. Sample Size: 150 participants (including equal representation of males and females). Geographic Representation: Both permanent residents of Shanghai and non-residents who have been in the city for less than 30 days will be included. The proportion of local residents to non-residents will range from 1:1 to 2:1. |
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| Elderly Healthy Volunteers Group | Age Range: 60-75 years Health Status: Participants in this group must have good respiratory health and be generally healthy based on medical history, physical examination, and a health check-up within the past year. Body Mass Index (BMI): Must be between 19-26 kg/m² (inclusive), with a minimum weight of 50 kg for males and 45 kg for females. Sample Size: 150 participants (including equal representation of males and females). Geographic Representation: Similar to the young group, the elderly group will include both permanent residents of Shanghai and non-residents, with the same proportion of local residents to non-residents (1:1 to 2:1). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample Collection | Other | All participants will provide nasal and pharyngeal swabs for virome analysis. A subset of 30 elderly volunteers will also provide peripheral blood samples and undergo bronchoscopy under general anesthesia to collect upper and lower respiratory tract samples. |
| Measure | Description | Time Frame |
|---|---|---|
| Virome Composition and Diversity | Characterization of respiratory virome diversity in upper and lower respiratory tracts of healthy individuals, measured through viral sequencing of nasal, throat, and bronchoscopic samples. | From date of inclusion until the date of final quantification, assessed up to 6 months |
| Host Immune Response | Analysis of immune-related biomarkers and gene expression in blood samples, focusing on the interaction between respiratory virome diversity and the host immune response. | From date of inclusion until the date of final quantification, assessed up to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Virome and Demographic Correlation | Analysis of the correlation between virome composition and demographic factors such as age, gender, and geographic location. | From date of inclusion until the date of final quantification, assessed up to 6 months |
| Discovery of Unknown Viruses |
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1. Young Healthy Volunteers
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Exclusion Criteria:
2. Elderly Healthy Volunteers
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Exclusion Criteria:
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This study will include healthy Han Chinese individuals residing in Shanghai, divided into two age groups: young adults (20-35 years) and elderly individuals (60-75 years). A total of 300 participants will be recruited, regardless of gender. These participants will be selected based on good overall health, as determined by medical history, physical examination, and recent health checkup results.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiayang Yan, Ph. D | Contact | 86-19821839207 | yjy19960816@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jieming Qu, Ph. D | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200025 | China |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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Identification of novel viral sequences and their potential immunological significance in healthy individuals. |
| From date of inclusion until the date of final quantification, assessed up to 6 months |