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

NCT03379701 | Completed

• 1 other identifier: 0037-14
• Study Type: observational
• Target: 71
• Locations: 0 countries
• Sites: N/A

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).

Conditions

CRS

Keywords

chronic rhinosinusitis, nasal polyposis

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (7)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead
• The Technion: collaborator

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.

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: December 20, 2017
• Study Start: September 28, 2014
• Primary Completion: September 27, 2016
• Study Completion: September 27, 2016
• Last Updated: December 20, 2017

Record last verified: 2017-12