Chronic Rhinosinusitis (Diagnosis)TIPNCT04628442
Tissue Immune Interaction in Nasal Polyposis
An observational study of Chronic Rhinosinusitis (Diagnosis) and Chronic Rhinosinusitis With Nasal Polyps, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis), Chronic Rhinosinusitis With Nasal Polyps, Asthma
- What is being tested?
- Sinonasal Debridement Procedure, Nasal Polyp Removal and Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Nov 2020to 24 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with chronic rhinosinusitis who present with or without nasal polyps between the ages of 18 and 80 years.
Who may be able to join
- 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.
- Males or females between the ages 18 to 80 (inclusive)
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- 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.
Who cannot join
- 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
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Airway Clinical Research Center
San Francisco, California, 94143
About this study
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).
Read the 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.
- Being tested
- Sinonasal Debridement Procedure, Nasal Polyp Removal, Biopsy
- Keywords
- Asthma, Chronic Rhinosinusitis, Surgery
- Medical subject headings
- Disease, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinonasal Debridement ProcedureProcedure or surgery
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 RemovalProcedure or surgery
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.
BiopsyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sinonasal Debridement Procedure | |
| 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. Receives: Procedure: Nasal Polyp Removal; Procedure: Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start10 Nov 2020
- Primary completion24 Mar 2023
- Study completion24 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- John Fahy, MD, MSc, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04628442
- Sponsor's protocol ID
- 19-28725
- Other IDs
- 2P01HL107202-06A1
- Acronym
- TIP
- Status last verified
- Jul 2025
- First submitted
- 27 Feb 2020
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Immune Interaction in Nasal Polyposis
- ClinicalTrials.gov ID
- NCT04628442
- Acronym / sponsor ID
- TIP / 19-28725
- Keywords
- Asthma, Chronic Rhinosinusitis, Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 24 Mar 2023 (actual)
- Study completion
- 24 Mar 2023 (actual)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIP-OB (Office-Based) | – | Procedure: Sinonasal Debridement ProcedureThose 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) | – | Procedure: Nasal Polyp Removal, Procedure: BiopsyThose 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with chronic rhinosinusitis who present with or without nasal polyps between the ages of 18 and 80 years.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
- Smoking of tobacco or other recreational inhalants more than twice in the last month and/or >10 pack-year smoking history.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sinonasal Debridement ProcedureThis 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. | Procedure or surgery | TIP-OB (Office-Based) |
| Nasal Polyp RemovalThis 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 or surgery | TIP-OR (Operating Room) |
| BiopsyA 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. | Procedure or surgery | TIP-OR (Operating Room) |
Primary outcome
Percentage of ILC2 and tuft cells
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
- Airway Clinical Research Center websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Fahy, MD, MSc principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis (Diagnosis) and Chronic Rhinosinusitis With Nasal Polyps, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of ILC2 and tuft cells (time frame: Up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.