Tissue Immune Interaction in Nasal Polyposis
TIP
2 other identifiers
observational
38
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2020
CompletedStudy Start
First participant enrolled
November 10, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2023
CompletedJuly 30, 2025
July 1, 2025
2.4 years
February 27, 2020
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
TIP-OB (Office-Based)
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)
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.
Interventions
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.
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.
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.
Eligibility Criteria
Participants with chronic rhinosinusitis who present with or without nasal polyps between the ages of 18 and 80 years.
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCSF Airway Clinical Research Center
San Francisco, California, 94143, United States
Related Links
Biospecimen
Nasal polyp tissue collected from the nasal passages, inferior turbinate tissue collected form the nasal passages, mucus collected from the nasal passages, induced sputum, and blood.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John Fahy, MD, MSc
University of California, San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2020
First Posted
November 13, 2020
Study Start
November 10, 2020
Primary Completion
March 24, 2023
Study Completion
March 24, 2023
Last Updated
July 30, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share