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DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis

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.
 
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

Tracking Information
First Submitted Date October 26, 2009
First Posted Date October 27, 2009
Last Update Posted Date April 5, 2018
Study Start Date March 2005
Actual Primary Completion Date November 18, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis
Official Title DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Chronic Rhinosinusitis w/o Nasal Polyps
Intervention Not Provided
Study Groups/Cohorts
  • 1
    Chronic Rhinosinusitis w/o nasal polyps
  • 2
    No sinus disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October¬†26,¬†2009)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date November 18, 2008
Actual Primary Completion Date November 18, 2008   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01001819
Other Study ID Numbers 05-01-005E
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Marvin Fried, Montefiore Medical Center
Study Sponsor Montefiore Medical Center
Collaborators Not Provided
Investigators
Principal Investigator: Marvin P Fried, MD Montefiore Medical Center/Albert Einstein College of Medicine
PRS Account Montefiore Medical Center
Verification Date April 2018