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

Primary Purpose

Maxillary Sinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Specimen collection
Specimen collection
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Maxillary Sinusitis focused on measuring Chronic Rhinosinusitis, Sinus Disease, Allergy, Maxillary Sinus, Microarray

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California, San Francisco, Dept of Otolaryngology-HNS

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery

10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.

Outcomes

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.

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.

Full Information

First Posted
May 21, 2008
Last Updated
January 30, 2020
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT00683371
Brief Title
Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis
Official Title
Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
April 30, 2008 (Actual)
Study Completion Date
April 30, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Sinusitis
Keywords
Chronic Rhinosinusitis, Sinus Disease, Allergy, Maxillary Sinus, Microarray

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.
Intervention Type
Procedure
Intervention Name(s)
Specimen collection
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Specimen collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Goldberg, MD, MSCE
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco, Dept of Otolaryngology-HNS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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

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