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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

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.


Condition or disease Intervention/treatment
Chronic Rhinosinusitis Procedure: biopsy

Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : April 2010
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Group/Cohort Intervention/treatment
chronic rhinosinusitis with nasal polyps Procedure: biopsy
One or more biopsies from nasal mucosa will be harvested during surgery

chronic rhinosinusitis without nasal polyps Procedure: biopsy
One or more biopsies from nasal mucosa will be harvested during surgery

Control group Procedure: biopsy
One or more biopsies from nasal mucosa will be harvested during surgery




Biospecimen Retention:   Samples With DNA
Nasal mucosa and nasal polyps


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients referred to sinonasal surgery at Ahus, Norway
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

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): NCT01084811


Contacts
Contact: Kjell-Arild Danielsen, MD 93402150 ext +47 Kjell.Arild.Danielsen@ahus.no

Locations
Norway
Ahus Recruiting
Lørenskog, Akershus, Norway, 1478
Contact: Erik S Lie, MD    90687197 ext +47    Erik.S.Lie@ahus.no   
Principal Investigator: Kjell-Arild Danielsen, MD         
Sponsors and Collaborators
University Hospital, Akershus

Responsible Party: Erik S Lie, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT01084811     History of Changes
Other Study ID Numbers: 2009/1720(REK)
First Posted: March 11, 2010    Key Record Dates
Last Update Posted: July 7, 2011
Last Verified: July 2010

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases