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

NCT00683371 | Completed

• 1 other identifier: H43796-31316-03
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Maxillary Sinusitis

Keywords

Chronic Rhinosinusitis; Sinus Disease; Allergy; Maxillary Sinus; Microarray

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediate Preoperative period.

Secondary Outcomes (1)

• 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.

  Immediate preoperative period

Study Arms (2)

1

ACTIVE COMPARATOR

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

Procedure: Specimen collection

2

PLACEBO COMPARATOR

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

Procedure: Specimen collection

Interventions

Specimen collection PROCEDURE

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Control patients with any evidence of CRS, by history, survey, or imaging criteria would be excluded.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

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

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Maxillary Sinusitis; Paranasal Sinus Diseases; Hypersensitivity

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Sinusitis; Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Andrew Goldberg, MD, MSCE

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2008
• First Posted: May 23, 2008
• Study Start: October 1, 2007
• Primary Completion: April 30, 2008
• Study Completion: April 30, 2008
• Last Updated: February 5, 2020

Record last verified: 2020-01

Locations

US (1)