Human Sinonasal Mucosa Heterogeneity Study

July 2, 2026 updated by: Yanran Huang, First Affiliated Hospital, Sun Yat-Sen University

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

Recruiting

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

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will include adult participants undergoing clinically indicated sinonasal surgery. Sinonasal mucosal tissue samples may be collected from different anatomical sites of the nasal cavity and paranasal sinuses when available during the planned surgical procedure. Participants may include individuals with sinonasal inflammatory disease as well as individuals undergoing surgery for non-inflammatory sinonasal conditions, depending on clinical availability and protocol requirements. No study-specific treatment or intervention will be assigned.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
healthy control
healthy people
CRSwNP
CRSwNP patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Site-Specific Heterogeneity of Human Sinonasal Mucosa
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

June 25, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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