CRSNCT03379701
Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Chronic Sinusitis Subtypes by Respiratory Samples
An observational study of CRS, run by Hillel Yaffe Medical Center.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- CRS
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2014to 27 Sep 2016
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients age 18 or less, pregnant women
- Presence of HIV, hepatitis or any other potentially severe and infectious disease. Patient that had sinus surgery.
About this study
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).
Read the 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.
- Conditions
- CRS
- Keywords
- chronic rhinosinusitis, nasal polyposis
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
discrimination between healthy and CRS subtypes based on SNOT 22 questionnaire results
SNOT 22 score (score 0-110)
Measured: 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)
Measured: Change of electrical resistance from recruitment and every six month until 3 years after recruitment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start28 Sep 2014
- Primary completion27 Sep 2016
- Study completion27 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CRSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 71 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- The Technion
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379701
- Sponsor's protocol ID
- 0037-14
- Status last verified
- Dec 2017
- First submitted
- 22 Nov 2017
- Last updated
- 20 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applications of Nanotechnology and Chemical Sensors for the Detection and Identification of Chronic Sinusitis Subtypes by Respiratory Samples
- ClinicalTrials.gov ID
- NCT03379701
- Acronym / sponsor ID
- 0037-14
- Conditions
- CRS
- Keywords
- chronic rhinosinusitis, nasal polyposis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- The Technion
- Study start
- 28 Sep 2014 (actual)
- Primary completion
- 27 Sep 2016 (actual)
- Study completion
- 27 Sep 2016 (actual)
- First posted
- 20 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- Patients age 18 or less, pregnant women
- Presence of HIV, hepatitis or any other potentially severe and infectious disease. Patient that had sinus surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of CRS, run by Hillel Yaffe Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.