DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Analysis of differential gene expression in patients with chronic rhinosinusitis without polyps compared to unaffected patients. Correlation of abnormal gene expression with surgical outcomes.
| Condition |
|---|
|
Chronic Rhinosinusitis w/o Nasal Polyps |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis |
| Estimated Enrollment: | 30 |
| Study Start Date: | March 2005 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Chronic Rhinosinusitis w/o nasal polyps
|
|
2
No sinus disease
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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
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.
Contacts and Locations| Contact: Marvin P Fried, MD | 718 920 2991 | mfried@montefiore.org |
| United States, New York | |
| Montefiore Medical Center | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Marvin P Fried, MD 718-920-2991 mfried@montefiore.org | |
| Principal Investigator: | Marvin P Fried, MD | Montefiore Medical Center/Albert Einstein College of Medicine |
More Information
No publications provided
| Responsible Party: | Marvin P. Fried, MD, Chariman Department of Otorhinolarygnology - Head & Neck Surgery, Montefiore Medical Center/Albert Einstein College of Medicine |
| ClinicalTrials.gov Identifier: | NCT01001819 History of Changes |
| Other Study ID Numbers: | 05-01-005E |
| Study First Received: | October 26, 2009 |
| Last Updated: | October 26, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Nasal Polyps Sinusitis Nose Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases |
Polyps Pathological Conditions, Anatomical Paranasal Sinus Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 16, 2013