Non Invasive Detection of Lung and Breast Cancer by Odor Signature

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02195076
• Other study ID #: 0695-13-SMC
• Status: Recruiting
• Phase: N/A
• First received: July 16, 2014
• Last updated: July 17, 2014
• Start date: July 2014

Study information

• Verified date: July 2014
• Source: BioSense Medical LTD
• Contact: Michal Mark Danieli, PhD
• Phone: +972-4-7706816
• Email: Michal[@]biosensem.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• non-invasive detection of cancer odor
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).

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer, Ramat- Gan

Sponsors (2)

Lead Sponsor	Collaborator
BioSense Medical LTD	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years	No
Secondary	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.	3 years	No