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

This study is currently recruiting participants.
Verified September 2013 by University of California, San Francisco
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00739921
First received: August 19, 2008
Last updated: September 23, 2013
Last verified: September 2013

August 19, 2008
September 23, 2013
June 2006
May 2015   (final data collection date for primary outcome 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). [ Time Frame: During the course of outpatient visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00739921 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA
PCR Analysis of Nasal Polyps for Fungal DNA

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 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.

Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Sinusitis
  • Nasal Polyps
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.

Experimental: 1

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: Procedure: Nasal swab under endoscopic guidance

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
260
May 2015
May 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunocompromise
  • Pregnancy
  • Minors
Both
18 Years and older
Yes
Contact: Wendy Ma 415-353-2870 wma@ohns.ucsf.edu
Contact: Andrew Murr, MD 415-353-2870 ahmurr@ohns.ucsf.edu
United States
 
NCT00739921
H9272-26987-05
No
University of California, San Francisco
University of California, San Francisco
Environmental Protection Agency (EPA)
Principal Investigator: Andrew Murr, MD University of California, San Francisco
University of California, San Francisco
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP