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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
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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).

Condition or disease Intervention/treatment
Chronic Rhinosinusitis (Diagnosis) Chronic Rhinosinusitis With Nasal Polyps Asthma 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 Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Groups and Cohorts
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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
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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Ariana Baum 415-514-1539 ariana.baum@ucsf.edu
Contact: Ndidi Njoku 415-476-1738 ndidi.njoku@ucsf.edu

Locations
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United States, California
UCSF Airway Clinical Research Center Recruiting
San Francisco, California, United States, 94143
Contact: Ariana Baum    415-514-1539    ariana.baum@ucsf.edu   
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         
Sponsors and Collaborators
University of California, San Francisco
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
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Principal Investigator: John Fahy, MD, MSc University of California, San Francisco
More Information
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Additional Information:

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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT04628442    
Other Study ID Numbers: 19-28725
2P01HL107202-06A1 ( U.S. NIH Grant/Contract )
First Posted: November 13, 2020    Key Record Dates
Last Update Posted: November 13, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of California, San Francisco:
Asthma
Chronic Rhinosinusitis
Surgery
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Respiratory Tract Diseases
Paranasal Sinus Diseases
Nose Diseases
 Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical