Tissue Immune Interaction in Nasal Polyposis (TIP)
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|ClinicalTrials.gov Identifier: NCT04628442|
Recruitment Status : Recruiting
First Posted : November 13, 2020
Last Update Posted : November 13, 2020
|Condition or disease||Intervention/treatment|
|Chronic Rhinosinusitis (Diagnosis) Chronic Rhinosinusitis With Nasal Polyps Asthma||Procedure: Sinonasal Debridement Procedure Procedure: Nasal Polyp Removal Procedure: Biopsy|
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|
|Estimated Enrollment :||100 participants|
|Official Title:||Tissue Immune Interaction in Nasal Polyposis|
|Actual Study Start Date :||November 10, 2020|
|Estimated Primary Completion Date :||March 2025|
|Estimated Study Completion Date :||March 2025|
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.
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.
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04628442
|Contact: Ariana Baumfirstname.lastname@example.org|
|Contact: Ndidi Njokuemail@example.com|
|United States, California|
|UCSF Airway Clinical Research Center||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Ariana Baum 415-514-1539 firstname.lastname@example.org|
|Principal Investigator: John Fahy, MD, MSc|
|Sub-Investigator: Mark Ansel, MD|
|Sub-Investigator: Nirav Bhakta, MD|
|Sub-Investigator: Erin Gordon, MD|
|Sub-Investigator: Monica Tang, MD|
|Sub-Investigator: Maya Kotas, MD, PhD|
|Sub-Investigator: Richard Locksley, MD|
|Sub-Investigator: Max Seibold, MD|
|Sub-Investigator: Prescott Woodruff, MD|
|Principal Investigator:||John Fahy, MD, MSc||University of California, San Francisco|