Tissue Immune Interaction in Nasal Polyposis

Recruiting

• Conditions: Chronic Rhinosinusitis With Nasal Polyps; Chronic Rhinosinusitis (Diagnosis); Asthma
• Interventions: Procedure: Sinonasal Debridement Procedure; Procedure: Nasal Polyp Removal; Procedure: Biopsy

• Registration Number: NCT04628442
• Lead Sponsor: University of California, San Francisco

Brief Summary

This is a cross-sectional study of up to 100 subjects who are undergoing clinically indicated sinus procedures to treat chronic rhinosinusitis. Participants will be asked to donate leftover sino-nasal secretions, sino-nasal tissue and blood as well as undergo partial characterization. As optional extensions of the main study, participants may also undergo a biopsy of extra sino-nasal tissue for additional tissue analysis and/or a more detailed characterization visit performed in the UCSF Airway Center Research Center (ACRC).

Detailed Description

This is a cross-sectional study of up to 100 participants who are undergoing clinically indicated sinus procedures to treat chronic rhinosinusitis. 50 participants with CRSwNP and 50 participants with CRS without polyps and no features of atopy will be enrolled in the study. Participants will donate leftover sino-nasal secretions and tissue from their procedures. In addition, participants will be subject to medical record review and research questionnaires.

In many instances, these participants will have multiple procedures over time to treat recurrent disease and this study will allow for them to donate leftover biospecimens as many as 9 times.

Participants may also opt to undergo a turbinate mucosal tissue biopsy during regularly scheduled sinus surgery for additional tissue analysis and/or undergo a more detailed, complete characterization visit performed in the UCSF Airway Center Research Center (ACRC). During the complete characterization, participants will undergo lung function tests, sputum induction and blood collection, in addition to the procedures mentioned above.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-02-27
• Study Start: 2020-11-10
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-13
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-10
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Males or females between the ages 18 to 80 (inclusive).
• History of blood eosinophils > 200 cells/dL (or tissue eosinophilia evident on histopathologic review of sino-nasal tissues).
• Physician diagnosis of chronic rhinosinusitis (CRS).
• Undergoing office-based or operating room-based sinus procedures for a clinical indication.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

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Exclusion Criteria

• Smoking of tobacco or other recreational inhalants more than twice in the last month and/or >10 pack-year smoking history.
• History of cystic fibrosis or ciliary dyskinesia.
• Currently taking immunosuppressant drugs including Mycophenolate mofetil (Cellcept), Cyclophosphamide (Cytoxan), Azathioprine (Imuran).

Participants with Chronic Rhinosinusitus without Nasal Polyps

Inclusion Criteria:

• Males or females between the ages 18 to 80 (inclusive)
• Physician diagnosis of CRS.
• Undergoing office-based or operating room-based sinus procedures for a clinical indication.
• Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

• Smoking of tobacco or other recreational inhalants more than twice in the last month and/or >10 pack-year smoking history.
• Presence of nasal polyps.
• History of allergic rhinitis.
• History of blood eosinophilia > 200 (or tissue eosinophilia evident on histopathologic review of sino-nasal tissues).
• Currently taking immunosuppressant drugs including Mycophenolate mofetil (Cellcept), Cyclophosphamide (Cytoxan), Azathioprine (Imuran).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TIP-OB (Office-Based)	Sinonasal Debridement Procedure	Those in TIP-OB will be undergoing regularly scheduled office-based procedures at the otolaryngology clinic at UCSF Mount Zion campus. The investigators will be collecting nasal mucus and blood samples during each of their visits to the clinic, up to 9 times.
TIP-OR (Operating Room)	Nasal Polyp Removal	Those in TIP-OR will be undergoing regularly scheduled surgeries in the operating room at UCSF Parnassus or Mount Zion campus. The investigators will be collected nasal polyp tissue, nasal mucus if possible, and blood samples during each of their surgeries, up to 9 times. The investigators will also collect inferior turbinate tissue if consented to.
TIP-OR (Operating Room)	Biopsy	Those in TIP-OR will be undergoing regularly scheduled surgeries in the operating room at UCSF Parnassus or Mount Zion campus. The investigators will be collected nasal polyp tissue, nasal mucus if possible, and blood samples during each of their surgeries, up to 9 times. The investigators will also collect inferior turbinate tissue if consented to.

Primary Outcome Measures

Name	Time	Method
Percentage of ILC2 and tuft cells	Up to 8 hours	This study enrolls chronic rhinosinusitis patients with and without nasal polyps. Investigators aim to compare the percentage of ILC2 and tuft cells present in nasal tissue and secretions between those who present with nasal polyps and without nasal polyps.

Trial Locations

Locations (1)

UCSF Airway Clinical Research Center; 🇺🇸 San Francisco, California, United States