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

NCT ID: NCT03379701

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-28

Study Completion Date

2016-09-27

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.

Conditions

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CRS

Keywords

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chronic rhinosinusitis, nasal polyposis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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CRSwPolyps with no Eosonophilia

CRS patients with nasal polyposis, and no eosonophilia.

No interventions assigned to this group

CRSwPolyps with Eosonopholia

CRS patients with nasal polyposis and eosonophilia.

No interventions assigned to this group

CRS without Polyps

Patients with chronic rhinosinusitis and no nasalpolyposis.

No interventions assigned to this group

PCD

Patients with Primrary ciliary dyskinesia .

No interventions assigned to this group

AFRS

Patients with allergic fungal rhinosinusitis.

No interventions assigned to this group

allergic rhinitis

Patients with allergic rhinitis

No interventions assigned to this group

Control

Healthy subjects.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Technion

UNKNOWN

Sponsor Role collaborator

Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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0037-14

Identifier Type: -

Identifier Source: org_study_id