Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers

Recruiting

• Conditions: Healthy

• Registration Number: NCT06120244
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary

Background:

Infections in the lower respiratory tract (lungs) are the leading cause of death from infectious disease worldwide. This was true even before the COVID-19 pandemic. Respiratory viruses are still a major health threat. Many of these viruses infect people by penetrating the thin skin that lines the nose. These viruses can also spread easily to other people when they multiply in the tissues that line the nose. Researchers want to learn more about what these viruses do inside the nose, how they get from the nose to the lungs, and how they spread from person to person.

Objective:

To collect cell samples from inside the noses of healthy people. These cells will be stored for use in future research on respiratory diseases.

Eligibility:

Healthy volunteers aged 18 years and older.

Design:

Most participants will have 1 visit on 1 day. They will be asked questions. Those who have a runny nose, coughing, congestion, or fever will be asked to wait up to 21 days before participating.

Participants will be given a slender swab with small bristles at the end. They will rub the inside of their nose with the swab. A clinic staff member will be present to help, if needed.

Participants will provide their name, age, and sex. This information will be encoded so that only certain researchers will know the participants identities.

Participants will not be contacted again....

Detailed Description

Study Description:

This is a repository protocol with prospective sample collection to provide samples needed for future studies of the pathogenesis of emerging respiratory viruses. Nasal brushings will be collected from approximately 100 healthy volunteers at RML and stored in the LV to be made available for future research studies that will be conducted under separate protocols, as applicable.

Primary Objective:

To obtain nasal epithelium brushes from healthy volunteers for 1) establishment of upper respiratory tract organoids, 2) assay validation, and 3) use for research into the pathogenesis of emerging respiratory viruses.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-11-01
• Study First Submitted: 2023-11-04
• Study First Submitted QC: 2023-11-04
• Study First Posted: 2023-11-07
• Status Verified: 2024-12-02
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-04
• Primary Completion: 2033-10-31
• Study Completion: 2033-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To obtain nasal epithelium brushes from healthy volunteers for 1) establishment of upper respiratory tract organoids, 2) assay validation, and 3) use for research into the pathogenesis of emerging respiratory viruses.	10 years	To obtain nasal epithelium brushes from healthy volunteers for 1) establishment of upper respiratory tract organoids, 2) assay validation, and 3) use for research into the pathogenesis of emerging respiratory viruses.

Trial Locations

Locations (1)

Rocky Mountain Laboratories; 🇺🇸 Hamilton, Montana, United States