Lung CancerNCT02195076
Non Invasive Detection of Lung and Breast Cancer by Odor Signature
An observational study of Lung Cancer and Breast Cancer, run by BioSense Medical LTD at 1 site in Israel.
Trial summary
The investigators have developed an early detection solution for lung and breast cancer. A system which can distinguish between different medical odors based on biosensors. Our product is user-friendly noninvasive, nonradioactive and nontoxic to the patients. Read more about this study
- Who is it for?
- Ages 30 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Breast Cancer
- What is being tested?
- non-invasive detection of cancer odor
- How many people
- 400 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Jul 2017
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 30 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Breast Cancer patient after diagnosis. Lung Cancer patients after diagnosis. Healthy controls, matching gender and age.
Who may be able to join
- Diagnosed Lung Cancer patients
- Diagnosed Breast Cancer patients
Who cannot join
- Cancer patients who were treated using chemotherapy
- Cancer patients who were treated using radiation
- Cancer patients who were treated using biological treatments
- Cancer patients who were treated with chemotherapy
- Cancer patients who were treated with any anti- cancer therapies
- Cancer patients who use drugs that affect the immune system
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Tel Hashomer, Ramat- Gan, 52621
Einav Gal-Yam, MD PhD, Einav.NiliGal-Yam@sheba.health.gov.il
Yair Bar, MD, Yair.bar@sheba.health.gov.il
About this study
Official title: A Clinical Study Design to Evaluate the Specificity and Sensitivity of Our Novel System for Detection of Breast and Lung Cancer by Odor Signature
The investigators have developed an early detection solution for lung and breast cancer. A system which can distinguish between different medical odors based on biosensors. Our product is user-friendly noninvasive, nonradioactive and nontoxic to the patients. The technology enables a high level of sensitivity and provides users with a quick lab response and a simple yes or no answer.
The aim of this study is to contribute and detect the patient at the earliest possible stage, in a noninvasive, nonradioactive and nontoxic way. Exhaled breath and urine samples are a promising approach towards future possible lung and breast cancer screening method.
Read the detailed description
Early detection of cancer can dramatically improve the survival chances. to date, there is no efficient diagnostic tool for detection of lung cancer in early stages. Regarding breast cancer, the common screening tool us mammography, which suffer from low sensitivity and high false positive. Thus, there is an urgent need for developing a screening tool for early stages lung and breast cancer.
The sense of smell depends on the ability of specialized sensory cells of the nose to perceive volatile compounds (VOCs). Diseases such as infections and malignancies can be associated with changes in host metabolism, accompanied by production of different VOCs, and thus a different odor. Several studies have shown that different cancers secrete different VOCs, thus produce different smell.
We have developed a system which uses biosensors that can scent the VOCs that lung and breast cancer cell produce, thus distinguish between healthy control and lung or breast cancer. These biosensors can detect low stages lung and breast cancer.
Patients will supply urine samples and exhaled breath samples using a kit that we will supply. The samples will be shipped to our lab, where they will be processed and the VOCs will be separated from the head space of the samples. The biosensors will be exposed to the VOCs samples and will report whether the specific sample id cancerous (lung or breast) or not.
The Data will be collected from all samples and statistical analysis will be calculated, in order to test the specificity and sensitivity of our biosensors to detect cancerous samples.
- Conditions
- Lung Cancer, Breast Cancer
- Being tested
- non-invasive detection of cancer odor
- Keywords
- Lung cancer, Breast Cancer, Biosensors, Volatile Organic Compounds, Odor, Urine Sample, Exhaled Breath Samples
- Medical subject headings
- Lung Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive detection of cancer odorOther
The odor VOCs of the specimens will be subjected to our system for detection by the biosensors. If the sample is cancerous the biosensors will report it (YES signal). If the sample s not cancerous, the biosensors will not report it (NO signal).
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer patients | Not described Receives: Other: non-invasive detection of cancer odor | |
| Lung cancer patients | Not described Receives: Other: non-invasive detection of cancer odor | |
| Healthy controls | Not described Receives: Other: non-invasive detection of cancer odor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of our biosensors in lung and breast cancer detection
We will measure the ability of our biosensors to detect lung and breast cancer in urine samples from patients. Each urine sample will be subjected to 5 biosensors. If 3 out of 5 will report positively, the sample will be marked as cancerous. Each type of cancer (lung or breast) will be detected by different groups of biosensors, trained specifically to detect the specific cancer type.
After the data of the detections will be collected, statistical analysis will be calculated in order to evaluate the sensitivity and specificity of our biosensor in cancer detection.
Measured: 3 years
Secondary outcomes (1)
Testing the ability of our biosensors to distinguish between different sub- types of breast and lung cancer.
After the collection of the detection data (primary outcome measure), we will compare it to the patients data records (in terms of staging, CT, pathology, biological markers etc.) and evaluate whether our biosensors can detect different sub- types of lung and breast cancer in different sensitivity and specifity.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- BioSense Medical LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02195076
- Sponsor's protocol ID
- 0695-13-SMC
- Status last verified
- Jul 2014
- First submitted
- 16 Jul 2014
- Last updated
- 21 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Design to Evaluate the Specificity and Sensitivity of Our Novel System for Detection of Breast and Lung Cancer by Odor Signature
- ClinicalTrials.gov ID
- NCT02195076
- Acronym / sponsor ID
- 0695-13-SMC
- Conditions
- Lung Cancer, Breast Cancer
- Keywords
- Lung cancer, Breast Cancer, Biosensors, Volatile Organic Compounds, Odor, Urine Sample, Exhaled Breath Samples
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- BioSense Medical LTDIndustry (pharma, biotech, devices)
- Collaborators
- Sheba Medical Center
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (estimated)
- First posted
- 21 Jul 2014 (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.
The investigators have developed an early detection solution for lung and breast cancer. A system which can distinguish between different medical odors based on biosensors. Our product is user-friendly noninvasive, nonradioactive and nontoxic to the patients. The technology enables a high level of sensitivity and provides users with a quick lab response and a simple yes or no answer.
The aim of this study is to contribute and detect the patient at the earliest possible stage, in a noninvasive, nonradioactive and nontoxic way. Exhaled breath and urine samples are a promising approach towards future possible lung and breast cancer screening method.
Detailed description
Early detection of cancer can dramatically improve the survival chances. to date, there is no efficient diagnostic tool for detection of lung cancer in early stages. Regarding breast cancer, the common screening tool us mammography, which suffer from low sensitivity and high false positive. Thus, there is an urgent need for developing a screening tool for early stages lung and breast cancer.
The sense of smell depends on the ability of specialized sensory cells of the nose to perceive volatile compounds (VOCs). Diseases such as infections and malignancies can be associated with changes in host metabolism, accompanied by production of different VOCs, and thus a different odor. Several studies have shown that different cancers secrete different VOCs, thus produce different smell.
We have developed a system which uses biosensors that can scent the VOCs that lung and breast cancer cell produce, thus distinguish between healthy control and lung or breast cancer. These biosensors can detect low stages lung and breast cancer.
Patients will supply urine samples and exhaled breath samples using a kit that we will supply. The samples will be shipped to our lab, where they will be processed and the VOCs will be separated from the head space of the samples. The biosensors will be exposed to the VOCs samples and will report whether the specific sample id cancerous (lung or breast) or not.
The Data will be collected from all samples and statistical analysis will be calculated, in order to test the specificity and sensitivity of our biosensors to detect cancerous samples.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer patients | – | Other: non-invasive detection of cancer odor |
| Lung cancer patients | – | Other: non-invasive detection of cancer odor |
| Healthy controls | – | Other: non-invasive detection of cancer odor |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Breast Cancer patient after diagnosis. Lung Cancer patients after diagnosis. Healthy controls, matching gender and age.
Key inclusion criteria (2 listed)
- Diagnosed Lung Cancer patients
- Diagnosed Breast Cancer patients
Key exclusion criteria (6 listed)
- Cancer patients who were treated using chemotherapy
- Cancer patients who were treated using radiation
- Cancer patients who were treated using biological treatments
- Cancer patients who were treated with chemotherapy
- Cancer patients who were treated with any anti- cancer therapies
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 |
|---|---|---|
| non-invasive detection of cancer odorThe odor VOCs of the specimens will be subjected to our system for detection by the biosensors. If the sample is cancerous the biosensors will report it (YES signal). If the sample s not cancerous, the biosensors will not report it (NO signal). | Other | Breast Cancer patients, Healthy controls, Lung cancer patients |
Primary outcome
The sensitivity and specificity of our biosensors in lung and breast cancer detection
Time frame: 3 years
We will measure the ability of our biosensors to detect lung and breast cancer in urine samples from patients. Each urine sample will be subjected to 5 biosensors. If 3 out of 5 will report positively, the sample will be marked as cancerous. Each type of cancer (lung or breast) will be detected by different groups of biosensors, trained specifically to detect the specific cancer type. After the data of the detections will be collected, statistical analysis will be calculated in order to evaluate the sensitivity and specificity of our biosensor in cancer detection.
1 secondary outcome
Testing the ability of our biosensors to distinguish between different sub- types of breast and lung cancer.
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Breast Cancer, run by BioSense Medical LTD at 1 site in Israel.
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 2 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michal Mark Danieli, PhD (+972-4-7706816, Michal@biosensem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of our biosensors in lung and breast cancer detection (time frame: 3 years). 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 21 Jul 2014.