- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683371
Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis
January 30, 2020 updated by: University of California, San Francisco
Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays in order to detect bacteria, fungi and viruses.
Ten control patients with normal sinuses will have the same samples taken.
The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Mucosal biopsies, endoscopically-guided brush samples of mucus, and a saline lavage taken from the maxillary sinuses of ten CRS patients undergoing sinus surgery are analyzed using three microarrays: 16S rRNA PhyloChip (to detect bacteria), MycoChip (to detect fungi) and ViroChip (to detect viruses).
Ten control patients with normal sinuses, as assessed by CT scan and a sinusitis-specific survey, will have the same samples taken.
The hypothesis is that bacterial, fungal, and viral communities present in the maxillary sinus of patients with CRS are significantly different from those patients with healthy sinuses, and that microorganisms identified in patients with or without CRS will differ from previously published data obtained using other techniques.
Comparing diseased and control flora will provide insight into the relative contribution of each pathogen to CRS and may guide the development of future therapies.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
San Francisco, California, United States, 94143
- University of California, San Francisco, Dept of Otolaryngology-HNS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria (CRS patients):
- History of CRS as defined as symptoms (nasal discharge, nasal obstruction, facial pain and/or hyposmia) for >12 weeks despite therapy.
- Impaired CRS-specific quality of life (SNOT-20 score >1.5).
- Evidence of sinus disease on a CT scan (Lund MacKay score greater than or equal to 10).
- Patients with positive skin or RAST testing to an inhalant allergen and/or aspirin hypersensitivity will be included. Evidence of atopy is not required but will be recorded, along with serum IgE levels, when available.
Inclusion Criteria (Control patients):
- No history of CRS
- SNOT-20 score <1.0
- No evidence of sinus disease on preoperative imaging
Exclusion Criteria:
- Control patients with any evidence of CRS, by history, survey, or imaging criteria would be excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1
10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery
|
10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery.
The sinus mucosa, sinus mucus and a saline lavage will be collected.
The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.
10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.
The sinus mucosa, sinus mucus and a saline lavage will be collected.
The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.
|
Placebo Comparator: 2
10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.
|
10 patients with chronic rhinosinusitis will have three specimens collected from the maxillary sinus during surgery.
The sinus mucosa, sinus mucus and a saline lavage will be collected.
The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.
10 patients without sinus disease will have three specimens collected from the maxillary sinus during surgery.
The sinus mucosa, sinus mucus and a saline lavage will be collected.
The three samples will then be analyzed with microarrays looking for bacteria, fungi, and viruses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Microbial community profiling using the PhyloChip, MycoChip, and ViroChip will yield vast quantities of data to be reduced in dimensions for interpretation. Pathogens detected in the nasal mucus of patients with CRS will be compared to healthy controls.
Time Frame: Immediate Preoperative period.
|
Immediate Preoperative period.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The presence or absence of a given microorganism will be compared to previously published data obtained using either traditional culture methods or other genomic methods.
Time Frame: Immediate preoperative period
|
Immediate preoperative period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Andrew Goldberg, MD, MSCE, University of California, San Francisco
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2007
Primary Completion (Actual)
April 30, 2008
Study Completion (Actual)
April 30, 2008
Study Registration Dates
First Submitted
May 21, 2008
First Submitted That Met QC Criteria
May 22, 2008
First Posted (Estimate)
May 23, 2008
Study Record Updates
Last Update Posted (Actual)
February 5, 2020
Last Update Submitted That Met QC Criteria
January 30, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H43796-31316-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Maxillary Sinusitis
-
Cairo UniversityNot yet recruitingChronic Maxillary Sinusitis
-
Centre Hospitalier Intercommunal CreteilActive, not recruitingChronic Maxillary SinusitisFrance
-
Tampere University HospitalRecruitingMaxillary Sinusitis | Eustachian Tube Dysfunction | Sinusitis, Chronic | Sinusitis RecurrentFinland
-
Oulu University HospitalTampere University HospitalRecruitingSinusitis | Maxillary Sinusitis | Sinusitis, AcuteFinland
-
Loma Linda UniversityWithdrawnChronic Sinus Disease | Chronic Sinusitis, Ethmoidal | Chronic Sinusitis, Sphenoidal | Chronic Sinusitis - Maxillary Bilateral | Chronic Sinusitis - Frontoethmoidal
-
Cairo UniversityNot yet recruiting
-
Western Galilee Hospital-NahariyaUnknownMaxillary SinusitisIsrael
-
BayerCompletedMaxillary SinusitisUnited States, Argentina
-
Johnson & Johnson Pharmaceutical Research & Development...PriCara, Unit of Ortho-McNeil, Inc.Completed
Clinical Trials on Specimen collection
-
First Hospital of China Medical UniversityThe Second Hospital of Shandong University; The First People's Hospital of... and other collaboratorsRecruiting
-
University of California, San FranciscoNational Cancer Institute (NCI)RecruitingCancerUnited States
-
Baptist Health South FloridaNico Corporation; Miami Cancer InstituteNot yet recruitingGlioblastoma | Glioblastoma Multiforme | GliosarcomaUnited States
-
Mayo ClinicRecruitingCerebellar Ataxia | Spinocerebellar Ataxias | Nucleotide Repeat DiseaseUnited States
-
Winthrop University HospitalCompletedType 2 Diabetes | Diabetic Foot UlcerUnited States
-
Winthrop University HospitalCompleted
-
Nova Mentis Life Science CorpFourthWall TestingRecruitingAutism Spectrum Disorder | Fra(X) SyndromeUnited States
-
University of MichiganNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedSpinocerebellar Ataxia Type 3United States
-
Sohail RaoRecruitingSpecimens Are to be Collected From Subjects Who Are Having or Have Had a Fluid or Tissue Removed, a Biopsy or a Blood or Bone Marrow DrawUnited States
-
Chinese University of Hong KongRecruitingHeart Diseases | Kidney Diseases | Healthy | Diabetes | Cancer | Neurological Diseases or Conditions | Other DiseaseHong Kong