Characterization of Head and Neck Malignant Tumors Using an Electronic Nose (HNeNose)
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
collecting breath samples
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with head and neck tumors
- A patient can understand, read and sign the informed consent form, signing a consent form
- Age over 18
Exclusion Criteria:
- Known or second primary head and neck cancer
- Surgery to head and neck index tumor except for tumor biopsy
- Unsteady comorbidity
- Pregnancy
- breastfeeding
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
eNose breath samples
Arm Description
Outcomes
Primary Outcome Measures
Characterization of biochemical markers in breath samples of patients with head and neck cancer by using artificial olfactory system (electronic nose).
Secondary Outcome Measures
Full Information
NCT ID
NCT01816919
First Posted
March 20, 2013
Last Updated
July 30, 2015
Sponsor
Carmel Medical Center
Collaborators
Technion, Israel Institute of Technology
1. Study Identification
Unique Protocol Identification Number
NCT01816919
Brief Title
Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
Acronym
HNeNose
Official Title
Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carmel Medical Center
Collaborators
Technion, Israel Institute of Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
Approximately 60,000 new cases of head and neck cancer are diagnosed in the U.S. each year, accounting for about 5% of cancer cases diagnosed in North America and approximately 1-2% of cancer deaths.
Smoking and alcohol are the main risk factors for head and neck tumors and are recognized in 75% of cases. In contrast, consumption of fruits and vegetables was found to be a protective factor. The symptoms are varied and can include sore throat and / or neck, difficulty or pain in swallowing, difficulty in breathing and hoarseness, facial movement disorder and other.
Multidisciplinary decision making and treatment is important for these patients due to the complexity of treatment and short-and long-term complications resulting from chemotherapy, radiotherapy and surgical intervention.
About a third of patients are diagnosed with disease at stage 1 or 2. These patients are treated by surgery or radiation. Five years survival for patients diagnosed with stage I is around 90% and 70% for patients diagnosed with stage 2. Despite surgical and radiation treatment when patients present with locally advanced disease, only 30% -50% of them survive after five years. Therefore, many studies have been conducted in an attempt to improve prognosis. Improved results are seen in combination therapy with chemotherapy and radiation treatment.
Patient survival depends on the stage of the disease, hence the importance of early detection. Research Laboratory of Dr. Hossam Haick developed a device that simulates the human nose. The device reveals patterns of volatile organic compounds emitted by breathing cancer cells. This is why it is referred to as "electronic nose". It includes an array of tiny nanometer sized sensors connected to an electronic computation unit. Because of their small size and electrical properties, the sensors are able to "smell" the changes in the composition of the materials that characterize cancer. Discovery of bio - cancer markers using breath samples offers several advantages: a) The breath samples are not invasive; b) air exhaled contains mixtures less complex than those found in blood or urine, and c) breath tests allow direct monitoring in real-time.
In this study we want to test the reliability of the developed device in real clinical conditions. Another goal of these experiments is to characterize the differences between respiratory specimens for various disease stages and to examine whether there is a relationship between the results of the samples to tumor volume (calculated using diagnostic CT scans). Due to its simplicity, positive results will allow us to consider using the device as a screening device for head and neck cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eNose breath samples
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
collecting breath samples
Primary Outcome Measure Information:
Title
Characterization of biochemical markers in breath samples of patients with head and neck cancer by using artificial olfactory system (electronic nose).
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients with head and neck tumors
A patient can understand, read and sign the informed consent form, signing a consent form
Age over 18
Exclusion Criteria:
Known or second primary head and neck cancer
Surgery to head and neck index tumor except for tumor biopsy
Unsteady comorbidity
Pregnancy
breastfeeding
12. IPD Sharing Statement
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Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
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