The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA
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|ClinicalTrials.gov Identifier: NCT00739921|
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sinusitis Nasal Polyps||Procedure: Nasal swab under endoscopic guidance||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||260 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PCR Analysis of Nasal Polyps for Fungal DNA|
|Study Start Date :||June 2006|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||May 2015|
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
After the application of pontocaine and neosynephrine spray, the following will be done:
The samples will be refrigerated and analyzed using PCR to detect and speciate fungus.
- Quality of life (QOL) instruments: Medical Outcomes Study 36-Item Short Form (SF-36) and the Sino-Nasal Outcomes Study- 20 questions (SNOT-20). [ Time Frame: During the course of outpatient visit ]
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): NCT00739921
|United States, California|
|University of California, San Francisco, Dept of Otolaryngology-HNS|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Andrew Murr, MD||University of California, San Francisco|