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DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis

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ClinicalTrials.gov Identifier: NCT01001819
Recruitment Status : Completed
First Posted : October 27, 2009
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
Marvin Fried, Montefiore Medical Center

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.

Condition or disease
Chronic Rhinosinusitis w/o Nasal Polyps

Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis
Study Start Date : March 2005
Actual Primary Completion Date : November 18, 2008
Actual Study Completion Date : November 18, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
1
Chronic Rhinosinusitis w/o nasal polyps
2
No sinus disease




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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.

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


Locations
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
Sponsors and Collaborators
Montefiore Medical Center
Investigators
Principal Investigator: Marvin P Fried, MD Montefiore Medical Center/Albert Einstein College of Medicine

Responsible Party: Marvin Fried, Professor, Otorhinolaryngology, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT01001819     History of Changes
Other Study ID Numbers: 05-01-005E
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: April 5, 2018
Last Verified: April 2018

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