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Chronic Rhinosinusitis: Biochemical Markers and Biofilm

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ClinicalTrials.gov Identifier: NCT01084811
Recruitment Status : Unknown
Verified July 2010 by University Hospital, Akershus.
Recruitment status was:  Recruiting
First Posted : March 11, 2010
Last Update Posted : July 7, 2011
Sponsor:
Information provided by:
University Hospital, Akershus

Tracking Information
First Submitted Date March 10, 2010
First Posted Date March 11, 2010
Last Update Posted Date July 7, 2011
Study Start Date April 2010
Estimated Primary Completion Date December 2012   (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 Chronic Rhinosinusitis: Biochemical Markers and Biofilm
Official Title Not Provided
Brief Summary

The investigators will conduct a descriptive, prospective, three-armed study concerning the pathophysiology of chronic rhinosinusitis.

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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Nasal mucosa and nasal polyps
Sampling Method Non-Probability Sample
Study Population Patients referred to sinonasal surgery at Ahus, Norway
Condition Chronic Rhinosinusitis
Intervention Procedure: biopsy
One or more biopsies from nasal mucosa will be harvested during surgery
Study Groups/Cohorts
  • chronic rhinosinusitis with nasal polyps
    Intervention: Procedure: biopsy
  • chronic rhinosinusitis without nasal polyps
    Intervention: Procedure: biopsy
  • Control group
    Intervention: Procedure: biopsy
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 Unknown status
Estimated Enrollment
 (submitted: March¬†10,¬†2010)
230
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of chronic rhinosinusitis based on EPOS3
  • Submitted to surgery
  • Using nasal corticosteroids

Exclusion Criteria:

  • Age below 18 years
  • Using antibiotics at the time of surgery
  • Using systemic corticosteroids
  • Sempers triad
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 Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01084811
Other Study ID Numbers 2009/1720(REK)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Erik S Lie, University Hospital, Akershus
Study Sponsor University Hospital, Akershus
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Akershus
Verification Date July 2010