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

Study Overview
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Brief Summary
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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
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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.

Official Title
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PCR Analysis of Nasal Polyps for Fungal DNA

Conditions
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Sinusitis, Nasal Polyps

Intervention / Treatment
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* Procedure: Nasal swab under endoscopic guidance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with no sinus disease and subjects with chronic rhinosinusitis. Exclusion Criteria: Immunocompromise Pregnancy Minors

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>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. | Procedure: Nasal swab under endoscopic guidance<br>* After the application of pontocaine and neosynephrine spray, the following will be done: A small sponge applicator will be used to swab the inside of your mouth for saliva collection A blood sample (6cc - one tube) will be collected A small brush applicator called a cytology brush and an instrument called an endoscope will be used to swab the inside of your nose (middle meatus) Subjects will be asked to complete 2 standard quality of life questionnaires regarding how much your symptoms bother you You will be asked to bring in a vacuum cleaner bag from home at a follow-up appointment which will be swabbed as well The samples will be refrigerated and analyzed using PCR to detect and speciate fungus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCR Analysis, Allergic fungal sinusitis, Chronic rhinosinusitis, Nasal Polyps