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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04628442
Other study ID # 19-28725
Secondary ID 2P01HL107202-06A
Status Recruiting
Phase
First received
Last updated
Start date November 10, 2020
Est. completion date March 2025

Study information

Verified date February 2023
Source University of California, San Francisco
Contact Xavier Orain, BS
Phone 415-502-3472
Email xavier.orain@ucsf.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Participants with Chronic Rhinosinusitus with Nasal Polyps 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. 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).

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Sinonasal Debridement Procedure
This is a medical procedure prescribed by the participant's physician that has been deemed necessary for patient care in order to address their chronic rhinosinusitis.
Nasal Polyp Removal
This is a surgical procedure prescribed by the participant's physician that has been deemed necessary for patient care in order to address their chronic rhinosinusitis.
Biopsy
A biopsy is optional and will remove a sample of inferior turbinate tissue from the nasal passage. It will be performed during a nasal polyp removal surgery already scheduled for patient care.

Locations

Country Name City State
United States UCSF Airway Clinical Research Center San Francisco California

Sponsors (3)

Lead Sponsor Collaborator
University of California, San Francisco National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of ILC2 and tuft cells 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. Up to 8 hours
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