DNA Microarray Analysis of Gene Expression in Chronic Rhinosinusitis

NCT ID: NCT01001819

Last Updated: 2018-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-11-18

Brief Summary

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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

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Conditions

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Chronic Rhinosinusitis w/o Nasal Polyps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Chronic Rhinosinusitis w/o nasal polyps

No interventions assigned to this group

2

No sinus disease

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Marvin Fried

Professor, Otorhinolaryngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marvin P Fried, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center/Albert Einstein College of Medicine

Locations

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Montefiore Medical Center

The Bronx, New York, United States

Site Status

Countries

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United States

Other Identifiers

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05-01-005E

Identifier Type: -

Identifier Source: org_study_id

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