Clinical trial NCT01001819: DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis
Official title: DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis w/o Nasal Polyps
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic Rhinosinusitis w/o nasal polyps who meet eligibilty requirements and are undergoing sinus surgery and patients w/o sinus disease who are undergoing intranasal surgery and meet eligbility requirements

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: 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.

  1. Patients deny recent (within one year) cigarette smoking or exposure to inhaled substances that are potentially harmful to respiratory epithelium.
  2. 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Marvin P Fried, MD
role: PRINCIPAL_INVESTIGATOR
References: