Tissue Immune Interaction in Nasal Polyposis (TIP)

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).

Study Overview

• Status: Completed
• Conditions: Asthma; Chronic Rhinosinusitis (Diagnosis); Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Procedure: Sinonasal Debridement Procedure; Procedure: Nasal Polyp Removal; Procedure: Biopsy

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.

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • UCSF Airway Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic rhinosinusitis who present with or without nasal polyps between the ages of 18 and 80 years.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	Procedure: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: John Fahy, MD, MSc, University of California, San Francisco

Publications and helpful links

Helpful Links

• Airway Clinical Research Center website

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2020
• Primary Completion (Actual): March 24, 2023
• Study Completion (Actual): March 24, 2023

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Asthma; Surgery; Chronic Rhinosinusitis
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Paranasal Sinus Diseases; Polyps; Rhinosinusitis; Nasal Polyps; Sinusitis
• Other Study ID Numbers: 19-28725; 2P01HL107202-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No