Head and Neck Cancer Clinical Trial
— HNeNoseOfficial title:
Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
Verified date | March 2013 |
Source | Carmel Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ethics Commission |
Study type | Interventional |
Head and neck tumors are common in the general population especially in high risk groups of
smokers and alcohol abusers, as well as after exposure to various environmental factors.
Diagnosis is based on identification of patients gross disease after a physical examination
and various imaging methods, and characterization of tissue mainly by fine-needle puncture
(FNA) and biopsy. Determining the stage of disease is based on physical examination, imaging
and tissue samples.
Using the electronic nose technology we hope to identify microscopic disease when it is
suspected or in populations in risk, thus diagnose patients in the initial stages of the
disease. Obviously, early diagnosis and treatment decisions will hopefully improve the
prognosis.
Finding a positive correlation between the stages, levels and various tumor volume and
respiratory specimens findings will classify patients more accurately and contribute to
further characterization of the disease in a more accurate, rapid and non-invasive fashion.
Status | Completed |
Enrollment | 100 |
Est. completion date | September 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with head and neck tumors 2. A patient can understand, read and sign the informed consent form, signing a consent form 3. Age over 18 Exclusion Criteria: 1. Known or second primary head and neck cancer 2. Surgery to head and neck index tumor except for tumor biopsy 3. Unsteady comorbidity 4. Pregnancy 5. breastfeeding |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Carmel Medical Center | Technion, Israel Institute of Technology |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Characterization of biochemical markers in breath samples of patients with head and neck cancer by using artificial olfactory system (electronic nose). | one year | No |
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