The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA

Not Applicable

Completed

• Conditions: Sinusitis; Nasal Polyps
• Interventions: Procedure: Nasal swab under endoscopic guidance

• Registration Number: NCT00739921
• Lead Sponsor: University of California, San Francisco

Brief Summary

The objective of this study is to determine whether the amount or type of fungal DNA present in the nose and home environment can be correlated with the outcomes of the following quality of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the Sino-Nasal Outcomes Study - 20 Questions (SNOT-20).

Detailed Description

The objective of this study is to determine whether the amount or type of fungal DNA present in the nose and home environment can be correlated with the outcomes of the following quality of life (QOL) instruments: Medical Outcomes Study 36-item Short Form (SF-36) and the Sino-Nasal Outcomes Study - 20 Questions (SNOT-20).

The study design involves case control Polymerase Chain reaction (PCR) analysis of nasal mucosal swabs, saliva swabs, blood serum, and home vacuum cleaner bags in patients with sinusitis and normal controls.

The hypothesis is that the quantity and type of fungal DNA present in the nose and home environment are directly correlated with quality of life. Our research aims to both quantify the amount of fungi present in the nasal mucosa as well as to measure the severity of the patient's chronic rhinosinusitis (CRS) as a function of SNOT-20 and SF-36 outcomes questionnaires. We hypothesize that the amount and type of fungi present in the nose and home environment will correlate with the severity of the patients' symptoms of CRS.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-06
• Study First Submitted: 2008-08-19
• Study First Submitted QC: 2008-08-20
• Study First Posted: 2008-08-22
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• Subjects with no sinus disease and subjects with chronic rhinosinusitis.

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Exclusion Criteria

• Immunocompromise
• Pregnancy
• Minors

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Nasal swab under endoscopic guidance	Patients with sinusitis compared to patients without. To find out if any specific type of fungus or mold is correlated with chronic sinus disease. The study will add new information about the different types of fungus and mold found in the human nose.

Primary Outcome Measures

Name	Time	Method
Quality of life (QOL) instruments: Medical Outcomes Study 36-Item Short Form (SF-36) and the Sino-Nasal Outcomes Study- 20 questions (SNOT-20).	During the course of outpatient visit

Trial Locations

Locations (1)

University of California, San Francisco, Dept of Otolaryngology-HNS; 🇺🇸 San Francisco, California, United States