The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA
Primary Purpose
Sinusitis, Nasal Polyps
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal swab under endoscopic guidance
Sponsored by
About this trial
This is an interventional diagnostic trial for Sinusitis focused on measuring PCR Analysis, Allergic fungal sinusitis, Chronic rhinosinusitis, Nasal Polyps
Eligibility Criteria
Inclusion Criteria:
- Subjects with no sinus disease and subjects with chronic rhinosinusitis.
Exclusion Criteria:
- Immunocompromise
- Pregnancy
- Minors
Sites / Locations
- University of California, San Francisco, Dept of Otolaryngology-HNS
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
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.
Outcomes
Primary Outcome Measures
Quality of life (QOL) instruments: Medical Outcomes Study 36-Item Short Form (SF-36) and the Sino-Nasal Outcomes Study- 20 questions (SNOT-20).
Secondary Outcome Measures
Full Information
NCT ID
NCT00739921
First Posted
August 19, 2008
Last Updated
December 2, 2019
Sponsor
University of California, San Francisco
Collaborators
Environmental Protection Agency (EPA)
1. Study Identification
Unique Protocol Identification Number
NCT00739921
Brief Title
The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA
Official Title
PCR Analysis of Nasal Polyps for Fungal DNA
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Environmental Protection Agency (EPA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis, Nasal Polyps
Keywords
PCR Analysis, Allergic fungal sinusitis, Chronic rhinosinusitis, Nasal Polyps
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Nasal swab under endoscopic guidance
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with no sinus disease and subjects with chronic rhinosinusitis.
Exclusion Criteria:
Immunocompromise
Pregnancy
Minors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Murr, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco, Dept of Otolaryngology-HNS
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11224767
Citation
Catten MD, Murr AH, Goldstein JA, Mhatre AN, Lalwani AK. Detection of fungi in the nasal mucosa using polymerase chain reaction. Laryngoscope. 2001 Mar;111(3):399-403. doi: 10.1097/00005537-200103000-00006.
Results Reference
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PubMed Identifier
15091220
Citation
Scheuller MC, Murr AH, Goldberg AN, Mhatre AN, Lalwani AK. Quantitative analysis of fungal DNA in chronic rhinosinusitis. Laryngoscope. 2004 Mar;114(3):467-71. doi: 10.1097/00005537-200403000-00015.
Results Reference
background
PubMed Identifier
15213523
Citation
Vesper SJ, Varma M, Wymer LJ, Dearborn DG, Sobolewski J, Haugland RA. Quantitative polymerase chain reaction analysis of fungi in dust from homes of infants who developed idiopathic pulmonary hemorrhaging. J Occup Environ Med. 2004 Jun;46(6):596-601. doi: 10.1097/01.jom.0000128160.17144.6e.
Results Reference
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The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA
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