Clinical trial NCT00739921: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sinusitis
Nasal Polyps
Keywords: PCR Analysis
Allergic fungal sinusitis
Chronic rhinosinusitis
Nasal Polyps
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Environmental Protection Agency (EPA)
First posted: 2008-08-22
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Immunocompromise
* Pregnancy
* Minors

Primary outcomes:
measure: Quality of life (QOL) instruments: Medical Outcomes Study 36-Item Short Form (SF-36) and the Sino-Nasal Outcomes Study- 20 questions (SNOT-20).
timeFrame: During the course of outpatient visit
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco, Dept of Otolaryngology-HNS
state: California
Study officials:
affiliation: University of California, San Francisco
name: Andrew Murr, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.