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Characterization of Head and Neck Malignant Tumors Using an Electronic Nose

18 Years
Open (Enrolling)
Head and Neck Cancer

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Trial Information

Characterization of Head and Neck Malignant Tumors Using an Electronic Nose

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

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

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.

Inclusion Criteria:

1. Patients with head and neck tumors

2. A patient can understand, read and sign the informed consent form, signing a consent

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Characterization of biochemical markers in breath samples of patients with head and neck cancer by using artificial olfactory system (electronic nose).

Outcome Time Frame:

one year

Safety Issue:



Israel: Ethics Commission

Study ID:




Start Date:

November 2010

Completion Date:

September 2013

Related Keywords:

  • Head and Neck Cancer
  • Neoplasms
  • Head and Neck Neoplasms