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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00739921
Recruitment Status : Completed
First Posted : August 22, 2008
Last Update Posted : December 4, 2019
Sponsor:
Collaborator:
Environmental Protection Agency (EPA)
Information provided by (Responsible Party):
University of California, San Francisco

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).

Condition or disease Intervention/treatment Phase
Sinusitis Nasal Polyps Procedure: Nasal swab under endoscopic guidance Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: PCR Analysis of Nasal Polyps for Fungal DNA
Study Start Date : June 2006
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds Sinusitis

Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Immunocompromise
  • Pregnancy
  • Minors

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00739921


Locations
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United States, California
University of California, San Francisco, Dept of Otolaryngology-HNS
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Environmental Protection Agency (EPA)
Investigators
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Principal Investigator: Andrew Murr, MD University of California, San Francisco
Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00739921    
Other Study ID Numbers: H9272-26987-05
First Posted: August 22, 2008    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Keywords provided by University of California, San Francisco:
PCR Analysis
Allergic fungal sinusitis
Chronic rhinosinusitis
Nasal Polyps
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases