Head and Neck CancerHNeNoseNCT01816919
Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
A study testing collecting breath samples in people with Head and Neck Cancer, run by Carmel Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- collecting breath samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2010to Sep 2013
- Phase
- Interventional
- 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
Who may be able to join
- Patients with head and neck tumors
- A patient can understand, read and sign the informed consent form, signing a consent form
- Age over 18
Who cannot join
- Known or second primary head and neck cancer
- Surgery to head and neck index tumor except for tumor biopsy
- Unsteady comorbidity
- Pregnancy
- breastfeeding
About this study
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- collecting breath samples
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collecting breath samplesOther
| Study group | Role | What they receive |
|---|---|---|
| eNose breath samples | Experimental | Not described Receives: Other: collecting breath samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of biochemical markers in breath samples of patients with head and neck cancer by using artificial olfactory system (electronic nose).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startNov 2010
- Primary completionApr 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816919
- Sponsor's protocol ID
- CMC-09-0075-CTIL
- Acronym
- HNeNose
- Status last verified
- Mar 2013
- First submitted
- 20 Mar 2013
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Head and Neck Malignant Tumors Using an Electronic Nose
- ClinicalTrials.gov ID
- NCT01816919
- Acronym / sponsor ID
- HNeNose / CMC-09-0075-CTIL
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Nov 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 22 Mar 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eNose breath samples | Experimental | Other: collecting breath samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with head and neck tumors
- A patient can understand, read and sign the informed consent form, signing a consent form
- Age over 18
Key exclusion criteria (5 listed)
- Known or second primary head and neck cancer
- Surgery to head and neck index tumor except for tumor biopsy
- Unsteady comorbidity
- Pregnancy
- breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collecting breath samples | Other | eNose breath samples |
Primary outcome
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
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 31 Jul 2015.
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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?
A study testing collecting breath samples in people with Head and Neck Cancer, run by Carmel 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 3 inclusion and 5 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 31 Jul 2015. 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?
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). 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 31 Jul 2015.