Breast Cancer Clinical Trial
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.
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.
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Observational Model: Case Control, Time Perspective: Prospective
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