Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by John Fahy, MD, MSc
Photo of John Fahy
John Fahy

Description

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).

Details

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.

Keywords

Chronic Rhinosinusitis (Diagnosis) Chronic Rhinosinusitis With Nasal Polyps Asthma Chronic Rhinosinusitis Surgery Sinusitis Nasal Polyps Sinonasal Debridement Procedure Nasal Polyp Removal Biopsy TIP-OB (Office-Based)

Eligibility

For people ages 18-80

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).

Location

  • UCSF Airway Clinical Research Center accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • John Fahy, MD, MSc
    I am a Professor of Medicine in the Division of Pulmonary and Critical Care Medicine and the Department of Medicine at UCSF. I direct a research program in asthma and other airway diseases that is human centered and focused on uncovering disease mechanisms and improving treatment.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Airway Clinical Research Center website
ID
NCT04628442
Study Type
Observational
Last Updated