Clinical trial NCT02195076: Non Invasive Detection of Lung and Breast Cancer by Odor Signature
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Breast Cancer
Keywords: Lung cancer
Breast Cancer
Biosensors
Volatile Organic Compounds
Odor
Urine Sample
Exhaled Breath Samples
Lead sponsor: BioSense Medical LTD
Sponsor class: INDUSTRY
Collaborators: name: Sheba Medical Center
First posted: 2014-07-21
Enrollment: 400
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast Cancer patient after diagnosis. Lung Cancer patients after diagnosis. Healthy controls, matching gender and age.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed Lung Cancer patients
* Diagnosed Breast Cancer patients

Exclusion Criteria:

* 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

Primary outcomes:
measure: The sensitivity and specificity of our biosensors in lung and breast cancer detection
timeFrame: 3 years
Secondary outcomes:
measure: Testing the ability of our biosensors to distinguish between different sub- types of breast and lung cancer.
timeFrame: 3 years
Other outcomes:
Locations:
city: Tel Hashomer, Ramat- Gan
country: Israel
facility: Sheba Medical Center
Study officials:
References: