SinusitisNCT00739921
The Polymerase Chain Reaction (PCR) Analysis of Nasal Polyps for Fungal DNA
A study testing Nasal swab under endoscopic guidance in people with Sinusitis and Nasal Polyps, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sinusitis, Nasal Polyps
- What is being tested?
- Nasal swab under endoscopic guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with no sinus disease and subjects with chronic rhinosinusitis.
Who cannot join
- Immunocompromise
- Pregnancy
- Minors
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco, Dept of Otolaryngology-HNS
San Francisco, California, 94143
About this study
Official title: 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).
Read the 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
- Being tested
- Nasal swab under endoscopic guidance
- Keywords
- PCR Analysis, Allergic fungal sinusitis, Chronic rhinosinusitis, Nasal Polyps
- Medical subject headings
- Sinusitis, Nasal Polyps, Allergic Fungal Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal swab under endoscopic guidanceProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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. Receives: Procedure: Nasal swab under endoscopic guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life (QOL) instruments: Medical Outcomes Study 36-Item Short Form (SF-36) and the Sino-Nasal Outcomes Study- 20 questions (SNOT-20).
Measured: During the course of outpatient visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2008 (estimated)
- Study startJun 2006
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Environmental Protection Agency (EPA)
- Responsible party
- Sponsor
- Investigators
- Andrew Murr, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00739921
- Sponsor's protocol ID
- H9272-26987-05
- Status last verified
- Dec 2019
- First submitted
- 19 Aug 2008
- Last updated
- 4 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11224767Scheuller 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.
PubMed 15091220Vesper 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.
PubMed 15213523
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PCR Analysis of Nasal Polyps for Fungal DNA
- ClinicalTrials.gov ID
- NCT00739921
- Acronym / sponsor ID
- H9272-26987-05
- Conditions
- Sinusitis, Nasal Polyps
- Keywords
- PCR Analysis, Allergic fungal sinusitis, Chronic rhinosinusitis, Nasal Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Environmental Protection Agency (EPA)
- Study start
- Jun 2006
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Nasal swab under endoscopic guidancePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects with no sinus disease and subjects with chronic rhinosinusitis.
Key exclusion criteria (3 listed)
- Immunocompromise
- Pregnancy
- Minors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal swab under endoscopic guidanceAfter 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. | Procedure or surgery | 1 |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
- Background: PubMed 11224767Catten 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.
- Background: PubMed 15091220Scheuller 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.
- Background: PubMed 15213523Vesper 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Murr, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal swab under endoscopic guidance in people with Sinusitis and Nasal Polyps, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00739921, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2019.