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

NCT ID: NCT00739921

Last Updated: 2019-12-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-06-30
• Study Completion Date: 2015-05-31

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).

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.

Conditions

Sinusitis; Nasal Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Nasal swab under endoscopic guidance

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Immunocompromise
• Pregnancy
• Minors

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Environmental Protection Agency (EPA)

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrew Murr, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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

San Francisco, California, United States

Countries

United States

References

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. doi: 10.1097/00005537-200103000-00006.

Reference Type: BACKGROUND

PMID: 11224767 (View on PubMed)

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. doi: 10.1097/00005537-200403000-00015.

Reference Type: BACKGROUND

PMID: 15091220 (View on PubMed)

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. doi: 10.1097/01.jom.0000128160.17144.6e.

Reference Type: BACKGROUND

PMID: 15213523 (View on PubMed)

Other Identifiers

H9272-26987-05

Identifier Type: -

Identifier Source: org_study_id