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

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).

Study Overview

• Status: Completed
• Conditions: CRS

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 71

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

CRS patients will be recruited through the Rhinologic clinic at the Hillel Yaffe Medical Center, after signing an informed consent. Healthy individuals that meet the inclusion/ exclusion criterions will be recruited from among the patient's escorts to the clinic or patients coming for other surgeries (unrelated spouse or acquaintance after signing an informed consent.

Description

Inclusion Criteria:

1. CRS patients that presented in the Rhinologic clinic at the Hillel Yaffe Medical Center. CRS patients that never had FESS - endoscopic sinus surgery.
2. Willing and able to give inform consent

Control subjects:

1. 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.
2. Willing and able to give informed consent

Exclusion Criteria:

1. Patients age 18 or less, pregnant women
2. Presence of HIV, hepatitis or any other potentially severe and infectious disease. Patient that had sinus surgery.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
CRSwPolyps with no Eosonophilia; CRS patients with nasal polyposis, and no eosonophilia.
CRSwPolyps with Eosonopholia; CRS patients with nasal polyposis and eosonophilia.
CRS without Polyps; Patients with chronic rhinosinusitis and no nasalpolyposis.
PCD; Patients with Primrary ciliary dyskinesia .
AFRS; Patients with allergic fungal rhinosinusitis.
allergic rhinitis; Patients with allergic rhinitis
Control; Healthy subjects.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Collaborators: The Technion

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2014
• Primary Completion (Actual): September 27, 2016
• Study Completion (Actual): September 27, 2016

Study Registration Dates

• First Submitted: November 22, 2017
• First Submitted That Met QC Criteria: December 19, 2017
• First Posted (Actual): December 20, 2017

Study Record Updates

• Last Update Posted (Actual): December 20, 2017
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: chronic rhinosinusitis, nasal polyposis
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Paranasal Sinus Diseases; Nose Diseases; Sinusitis
• Other Study ID Numbers: 0037-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No