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

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ClinicalTrials.gov Identifier: NCT03379701
Recruitment Status : Completed
First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
The Technion
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:

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).


Condition or disease
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 [Patient Registry]
Actual Enrollment : 71 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Chronic Sinusitis Subtypes by Respiratory Samples
Actual Study Start Date : September 28, 2014
Actual Primary Completion Date : September 27, 2016
Actual Study Completion Date : September 27, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

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.



Primary Outcome Measures :
  1. discrimination between healthy and CRS subtypes based on SNOT 22 questionnaire results [ Time Frame: change in score from recruitment and every six month until 3 years after recruitment. ]
    SNOT 22 score (score 0-110)

  2. Successful discrimination between healthy and CRS subtypes based on sensor response (electrical resistance measurements) [ Time Frame: Change of electrical resistance from recruitment and every six month until 3 years after recruitment. ]
    Electrical resistance-Disease diagnosis based on breath analysis data classification using an artificial olfactory system (AKA, Electronic nose)


Biospecimen Retention:   Samples Without DNA
An overall of 2-4 liter breath samples will be collected in inert Mylar bags and immediately transferred to sorbent tubes.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03379701     History of Changes
Other Study ID Numbers: 0037-14
First Posted: December 20, 2017    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hillel Yaffe Medical Center:
chronic rhinosinusitis, nasal polyposis

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases