Completed

HNeNoseCharacterization of Head and Neck Malignant Tumors Using an Electronic Nose

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What is being tested

collecting breath samples

Other
Who is being recruted

Neoplasms

+ Neoplasms by Site

+ Head and Neck Neoplasms

Over 18 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: November 2010
See protocol details

Summary

Principal SponsorCarmel Medical Center
Last updated: July 31, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: November 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorCarmel Medical Center
Last updated: July 31, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

NeoplasmsNeoplasms by SiteHead and Neck Neoplasms

Criteria

3 inclusion criteria required to participate
A patient can understand, read and sign the informed consent form, signing a consent form

Age over 18

Patients with head and neck tumors

5 exclusion criteria prevent from participating
Known or second primary head and neck cancer

Pregnancy

Surgery to head and neck index tumor except for tumor biopsy

Unsteady comorbidity

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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