- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07692243
Human Sinonasal Mucosa Heterogeneity Study
Heterogeneity of Mucosa Across Different Human Sinonasal Sites: An Observational Study
This observational study aims to better understand how the lining of the nose and sinuses differs across different sinonasal sites in humans, including participants with and without sinonasal inflammatory disease. Mucosal tissue samples will be collected from participants who are undergoing clinically indicated sinonasal surgery. The study will compare tissue structure, gene expression, protein expression, and immune cell composition among different regions of the sinonasal mucosa.
By studying these differences, researchers hope to identify site-specific features of human sinonasal mucosa and improve understanding of normal and disease-related changes in the nose and sinuses. This study does not assign participants to any treatment or intervention. The findings may provide a foundation for future research on chronic rhinosinusitis, nasal polyps, and other sinonasal diseases.
Study Overview
Status
Conditions
Detailed Description
The human sinonasal mucosa lines different regions of the nasal cavity and paranasal sinuses and plays an important role in mucosal defense, inflammation, and tissue homeostasis. However, the biological characteristics of mucosa from different sinonasal sites are not fully understood.
This observational study will collect sinonasal mucosal tissue samples from participants undergoing clinically indicated sinonasal surgery. Samples may be obtained from different anatomical sites of the sinonasal tract when available as part of the surgical procedure. No treatment or intervention will be assigned by the study.
Collected samples will be analyzed to compare site-specific features of human sinonasal mucosa, including tissue structure, gene expression patterns, protein expression profiles, and immune cell composition. Relevant clinical information may also be collected to support interpretation of the biological findings.
The purpose of this study is to characterize the heterogeneity of human sinonasal mucosa across different anatomical sites. The results may help improve understanding of normal sinonasal mucosal biology and provide a reference for future studies of chronic rhinosinusitis, nasal polyps, and other sinonasal inflammatory diseases.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: YAN YAN, Master's Degree
- Phone Number: +8613016018473
- Email: yany38@mail2.sysu.edu.cn
Study Contact Backup
- Name: yanran huang, Doctor of Medicine
- Phone Number: 13016018473
- Email: yany38@mail2.sysu.edu.cn
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510030
- Recruiting
- the First Affiliated Hospital of Sun Yat-sen University
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Contact:
- Phone Number: 13016018473
- Email: yany38@mail2.sysu.edu.cn
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Contact:
- Email: yany38@mail2.sysu.edu.cn
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults aged 18 years or older.
- Scheduled for clinically indicated sinonasal surgery.
- Sinonasal mucosal tissue can be collected during surgery without significant additional risk.
- Able and willing to provide written informed consent.
- Relevant clinical information is available.
Exclusion Criteria:
- Unable or unwilling to provide informed consent.
- Younger than 18 years of age.
- Tissue collection may interfere with standard care or increase surgical risk.
- History of sinonasal malignancy, sinonasal radiotherapy, or chemotherapy affecting sinonasal mucosa.
- Active systemic infection or severe systemic disease affecting study participation or interpretation.
- Use of systemic corticosteroids, immunosuppressants, or biologics within 4 weeks before surgery.
- Insufficient or poor-quality tissue for planned analyses.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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healthy control
healthy people
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CRSwNP
CRSwNP patient
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Site-Specific Heterogeneity of Human Sinonasal Mucosa
Time Frame: Baseline
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Differences in histological features, gene expression patterns, protein expression profiles, and immune cell composition will be compared among mucosal tissue samples collected from different anatomical sites of the human sinonasal tract.
These analyses will be used to characterize site-specific biological features and support construction of a human sinonasal mucosal spatial atlas.
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Baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Human Sinonasal Mucosa Heterog
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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