Status:
COMPLETED
DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis
Lead Sponsor:
Montefiore Medical Center
Conditions:
Chronic Rhinosinusitis w/o Nasal Polyps
Eligibility:
All Genders
18+ years
Brief Summary
Analysis of differential gene expression in patients with chronic rhinosinusitis without polyps compared to unaffected patients. Correlation of abnormal gene expression with surgical outcomes.
Eligibility Criteria
Inclusion
- Affected patients:
- Two or more of the following symptoms should be present for 12 weeks or more: anterior mucopurulent drainage, posterior mucopurulent drainage; nasal obstruction; and facial pain-pressure-fullness.
- Signs of nasal inflammation such as discolored mucus, edema of the middle meatus or ethmoid area should be documented by endoscopy.
- The symptoms of rhinosinusitis have failed to resolve or have recurred after a treatment course with antibiotics and nasal and/or oral steroids.
- The diagnosis of rhinosinusitis should be confirmed with a CT scan.
- Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium
- Patients were not previously diagnosed with reactive airway disease or aspirin sensitivity.
- Patients also must meet the standard criteria for endoscopic sinus surgery and scheduled to undergo their procedure at MMC.
- Unaffected Patients:
- Patients undergoing elective nasal surgery at MMC.
- Patients deny symptoms of allergic rhinitis such as nasal congestion, nasal discharge, itching, sneezing.
- Patients deny symptoms of chronic or acute rhinosinusitis such as nasal obstruction, facial pain-fullness-pressure, anosmia, anterior and/or posterior mucopurulent drainage.
- Nasal endoscopy showed no evidence of nasal inflammatory disease, such as erythema, edema, polyps, or discolored mucus.
- Patients do not have history of prior sinus surgeries and were not previously diagnosed with CRS.
- Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium.
- Patients were not diagnosed with reactive airway disease or aspirin sensitivity.
- The absence of evidence of inflammation, such as inflammatory infiltrate or epithelial dysplasia on histopathologic exam of nasal mucosa obtained during surgical procedure.
Exclusion
Key Trial Info
Start Date :
March 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 18 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01001819
Start Date
March 1 2005
End Date
November 18 2008
Last Update
April 5 2018
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10467