Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Chronic Sinusitis Subtypes by Respiratory Samples

Study Overview
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Brief Summary
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Professor Hossam Haick from the Technion, developed an electronic nose for diagnosis of diseases via breath samples. Biomarkers from nose and sinuses and upper respiratory tract can be detected by electronic nose. Identification of biomarkers from nose and sinuses and upper respiratory tract can differentiate between the subtypes of CRS (Chronic rhinosinusitis) and may serve as markers for disease (vs controls), of disease activity (predicting aggressive disease course, predicting Malignant vs Benign nasal polyps, as inverted papillpma or carcinoma; predicting response to therapy (Steroid , Antibiotics, Nasal wash, Surgery).

Detailed Description
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Professor Hossam Haick from the Technion, developed an electronic nose for diagnosis of diseases via breath samples. Biomarkers from nose and sinuses and upper respiratory tract can be detected by electronic nose. Identification of biomarkers from nose and sinuses and upper respiratory tract can differentiate between the subtypes of CRS (Chronic rhinosinusitis) and may serve as markers for disease (vs controls), of disease activity (predicting aggressive disease course, predicting Malignant vs Benign nasal polyps, as inverted papillpma or carcinoma; predicting response to therapy (Steroid , Antibiotics, Nasal wash, Surgery). The aim of this study is to evaluate various CRS diseases with the Electronic Nose trying to better differentiate CRSwPolyps , CRS without Polyps, PCD, AFS, Vasculitis (as Wegener Granulomatosis) and Allergic Rhinitis with CRS. For that reason samples were taken from patients from different groups of CRS patients: 1. CRSwPolyps with no Eosonophilia , 2. CRSwPolyps with Eosonopholia, 3. CRS without Polyps, 4. PCD, 5. AFS, 6. allergic rhinitis and 7. Control subjects.

Official Title
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Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Chronic Sinusitis Subtypes by Respiratory Samples

Conditions
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CRS

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CRS patients that presented in the Rhinologic clinic at the Hillel Yaffe Medical Center. CRS patients that never had FESS - endoscopic sinus surgery. Willing and able to give inform consent Control subjects: Age and gender match control individuals that do not have CRS or any other condition that is defined as nasal disease. These individuals will be recruited as Healthy Population Reference group. Willing and able to give informed consent Exclusion Criteria: Patients age 18 or less, pregnant women Presence of HIV, hepatitis or any other potentially severe and infectious disease. Patient that had sinus surgery.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CRSwPolyps with no Eosonophilia<br>CRS patients with nasal polyposis, and no eosonophilia. | |
| CRSwPolyps with Eosonopholia<br>CRS patients with nasal polyposis and eosonophilia. | |
| CRS without Polyps<br>Patients with chronic rhinosinusitis and no nasalpolyposis. | |
| PCD<br>Patients with Primrary ciliary dyskinesia . | |
| AFRS<br>Patients with allergic fungal rhinosinusitis. | |
| allergic rhinitis<br>Patients with allergic rhinitis | |
| Control<br>Healthy subjects. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discrimination between healthy and CRS subtypes based on SNOT 22 questionnaire results | SNOT 22 score (score 0-110) | change in score from recruitment and every six month until 3 years after recruitment. | 
| Successful discrimination between healthy and CRS subtypes based on sensor response (electrical resistance measurements) | Electrical resistance-Disease diagnosis based on breath analysis data classification using an artificial olfactory system (AKA, Electronic nose) | Change of electrical resistance from recruitment and every six month until 3 years after recruitment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic rhinosinusitis, nasal polyposis