Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00683371
First received: May 21, 2008
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays in order to detect bacteria, fungi and viruses. Ten control patients with normal sinuses will have the same samples taken. The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques.


Condition Intervention
Maxillary Sinusitis
Procedure: Specimen collection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Microbial community profiling using the PhyloChip, MycoChip, and ViroChip will yield vast quantities of data to be reduced in dimensions for interpretation. Pathogens detected in the nasal mucus of patients with CRS will be compared to healthy controls. [ Time Frame: Immediate Preoperative period. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The presence or absence of a given microorganism will be compared to previously published data obtained using either traditional culture methods or other genomic methods. [ Time Frame: Immediate preoperative period ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery
Procedure: Specimen collection
10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery. The sinus mucosa, sinus mucus and a saline lavage will be collected. The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.
Placebo Comparator: 2
10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.
Procedure: Specimen collection
10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery. The sinus mucosa, sinus mucus and a saline lavage will be collected. The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.

Detailed Description:

Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays: 16S rRNA PhyloChip (to detect bacteria), MycoChip (to detect fungi) and ViroChip (to detect viruses). Ten control patients with normal sinuses, as assessed by CT scan and a sinusitis-specific survey, will have the same samples taken. The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques. Comparing diseased and control flora will provide insight into the relative contribution of each pathogen to CRS and may guide the development of future therapies.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria (CRS patients):

  • History of CRS as defined as symptoms (nasal discharge, nasal obstruction, facial pain and/or hyposmia) for >12 weeks despite therapy.
  • Impaired CRS-specific quality of life (SNOT-20 score >1.5).
  • Evidence of sinus disease on a CT scan (Lund MacKay score greater than or equal to 10).
  • Patients with positive skin or RAST testing to an inhalant allergen and/or aspirin hypersensitivity will be included. Evidence of atopy is not required but will be recorded, along with serum IgE levels, when available.

Inclusion Criteria (Control patients):

  • No history of CRS
  • SNOT-20 score <1.0
  • No evidence of sinus disease on preoperative imaging

Exclusion Criteria:

  • Control patients with any evidence of CRS, by history, survey, or imaging criteria would be excluded.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00683371

Contacts
Contact: Maria Mogannam 415-353-2870 maria.mogannam@ucsf.edu
Contact: Andrew N Goldberg, MD, MSCE 415-353-2086 agoldberg@ohns.ucsf.edu

Locations
United States, California
University of California, San Francisco, Dept of Otolaryngology-HNS Recruiting
San Francisco, California, United States, 94143
Contact: Maria Mogannan    415-353-2870    maria.mogannam@ucsf.edu   
Contact: Andrew Goldberg, MD, MSCE    415-353-2757    agoldberg@ohns.ucsf.edu   
Principal Investigator: Andrew Goldberg, MD, MSCE         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Andrew Goldberg, MD, MSCE University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00683371     History of Changes
Other Study ID Numbers: H43796-31316-03
Study First Received: May 21, 2008
Last Updated: June 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Chronic Rhinosinusitis
Sinus Disease
Allergy
Maxillary Sinus
Microarray

Additional relevant MeSH terms:
Maxillary Sinusitis
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014