Chronic Rhinosinusitis: Biochemical Markers and Biofilm
NCT ID: NCT01084811
Last Updated: 2011-07-07
Study Results
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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UNKNOWN
230 participants
OBSERVATIONAL
2010-04-30
2012-12-31
Brief Summary
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In one part of the study the investigators want to investigate the presence of biofilm in patients with chronic rhinosinusitis both with and without nasal polyps compared with a control group of subjects without chronic rhinosinusitis. The investigators will also compare quality of life in the three groups and correlate disease severity in biofilm patients versus patients where biofilm was not present.
The hypothesis here is that biofilm patients suffers a more severe disease.
In the other arm of the study the investigators will compare the presence of different biochemical compounds in the three study groups. The investigators specifically want to investigate matrix metalloproteases and apoptosis-inhibitors with immunohistochemistry. The investigators may also add other compounds to our test-battery if interesting candidates surface in the literature during the inclusion period.
The purpose of this part of the study is to investigate candidates for the development of nasal polyposis.
The investigators plan to include 100 patients suffering from chronic rhinosinusitis with nasal polyps, and 100 patients with chronic rhinosinusitis without nasal polyps and 30 control subjects.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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chronic rhinosinusitis with nasal polyps
biopsy
One or more biopsies from nasal mucosa will be harvested during surgery
chronic rhinosinusitis without nasal polyps
biopsy
One or more biopsies from nasal mucosa will be harvested during surgery
Control group
biopsy
One or more biopsies from nasal mucosa will be harvested during surgery
Interventions
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biopsy
One or more biopsies from nasal mucosa will be harvested during surgery
Eligibility Criteria
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Inclusion Criteria
* Submitted to surgery
* Using nasal corticosteroids
Exclusion Criteria
* Using antibiotics at the time of surgery
* Using systemic corticosteroids
* Sempers triad
18 Years
ALL
No
Sponsors
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University Hospital, Akershus
OTHER
Responsible Party
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University Hospital, Akershus
Locations
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Ahus
Lørenskog, Akershus, Norway
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2009/1720(REK)
Identifier Type: -
Identifier Source: org_study_id
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