Chronic Rhinosinusitis: Biochemical Markers and Biofilm

NCT01084811 | Unknown

• 1 other identifier: 2009/1720(REK)
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis

Study Arms (3)

chronic rhinosinusitis with nasal polyps

Procedure: biopsy

chronic rhinosinusitis without nasal polyps

Procedure: biopsy

Control group

Procedure: biopsy

Interventions

biopsy PROCEDURE

One or more biopsies from nasal mucosa will be harvested during surgery

Control group; chronic rhinosinusitis with nasal polyps; chronic rhinosinusitis without nasal polyps

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients referred to sinonasal surgery at Ahus, Norway

You may qualify if:

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

You may not qualify if:

• Age below 18 years
• Using antibiotics at the time of surgery
• Using systemic corticosteroids
• Sempers triad

Sponsors & Collaborators

• University Hospital, Akershus: lead

Study Sites (1)

Ahus

Lørenskog, Akershus, 1478, Norway

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nasal mucosa and nasal polyps

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Kjell-Arild Danielsen, MD

CONTACT

93402150; Kjell.Arild.Danielsen@ahus.no

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 7, 2011

Record last verified: 2010-07

Locations

NO (1)