Non Invasive Detection of Lung and Breast Cancer by Odor Signature

NCT ID: NCT02195076

Last Updated: 2014-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Brief Summary

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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

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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

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Lung Cancer Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast Cancer patients

non-invasive detection of cancer odor

Intervention Type OTHER

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).

Lung cancer patients

non-invasive detection of cancer odor

Intervention Type OTHER

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).

Healthy controls

non-invasive detection of cancer odor

Intervention Type OTHER

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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role collaborator

BioSense Medical LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sheba Medical Center

Tel Hashomer, Ramat- Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Michal Mark Danieli, PhD

Role: CONTACT

+972-4-7706816

Asher Castiel, PhD

Role: CONTACT

+972-4-7706816

Facility Contacts

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Einav Gal-Yam, MD PhD

Role: primary

Yair Bar, MD

Role: backup

Other Identifiers

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0695-13-SMC

Identifier Type: -

Identifier Source: org_study_id

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