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NCT Number: NCT00739921

The Polymerase Chain Reaction (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).

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Key information

Conditions

Sinusitis Allergic Fungal Sinusitis Bacterial Infections and Mycoses Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Infections Mycoses Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Hypersensitivity Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco, Dept of Otolaryngology-HNS

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Immunocompromise
  • Pregnancy
  • Minors

Treatment and study plan

Nasal swab under endoscopic guidance

Procedure

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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • Environmental Protection Agency (EPA)

Registry information

Official study title

PCR Analysis of Nasal Polyps for Fungal DNA

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Aug 22, 2008
Registry last updated
Dec 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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