Asthma Clinical Trial
— TIPOfficial title:
Tissue Immune Interaction in Nasal Polyposis
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).
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). |
Country | Name | City | State |
---|---|---|---|
United States | UCSF Airway Clinical Research Center | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) |
United States,
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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