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DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2009 by Montefiore Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01001819
First Posted: October 27, 2009
Last Update Posted: October 27, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Montefiore Medical Center
  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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001819


Contacts
Contact: Marvin P Fried, MD 718 920 2991 mfried@montefiore.org

Locations
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   
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Marvin P Fried, MD Montefiore Medical Center/Albert Einstein College of Medicine
  More Information

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
First Submitted: October 26, 2009
First Posted: October 27, 2009
Last Update Posted: October 27, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Sinusitis
Nasal Polyps
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical