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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 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: June 30, 2014
Last verified: June 2014
  Purpose

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).


Condition Intervention
Sinusitis
Nasal Polyps
Procedure: Nasal swab under endoscopic guidance

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PCR Analysis of Nasal Polyps for Fungal DNA

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

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). [ Time Frame: During the course of outpatient visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: June 2006
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunocompromise
  • Pregnancy
  • Minors
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00739921

Contacts
Contact: Maria Mogannam 415-353-2870 maria.mogannam@ucsf.edu
Contact: Andrew Murr, MD 415-353-2870 ahmurr@ohns.ucsf.edu

Locations
United States, California
University of California, San Francisco, Dept of Otolaryngology-HNS Recruiting
San Francisco, California, United States, 94143
Contact: Maria Mogannan    415-353-2870    maria.mogannan@ucsf.edu   
Contact: Andrew Murr, MD    415-353-2870    ahmurr@ohns.ucsf.edu   
Principal Investigator: Andrew Murr, MD         
Sub-Investigator: Andrew Goldberg, MD, MSCE         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Andrew Murr, MD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00739921     History of Changes
Other Study ID Numbers: H9272-26987-05
Study First Received: August 19, 2008
Last Updated: June 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
PCR Analysis
Allergic fungal sinusitis
Chronic rhinosinusitis
Nasal Polyps

Additional relevant MeSH terms:
Polyps
Sinusitis
Nasal Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on October 01, 2014