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

Sinusitis Clinical Trial

Official title:

PCR Analysis of Nasal Polyps for Fungal DNA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00739921
• Other study ID #: H9272-26987-05
• Status: Completed
• Phase: N/A
• Start date: June 2006
• Est. completion date: May 2015

Study information

• Verified date: December 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Immunocompromise

• Pregnancy

• Minors

Related Conditions & MeSH terms

• Nasal Polyps
• Polyps
• Sinusitis

Intervention

Procedure:
• Nasal swab under endoscopic guidance
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.

Locations

Country	Name	City	State
United States	University of California, San Francisco, Dept of Otolaryngology-HNS	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Environmental Protection Agency (EPA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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