Non Invasive Detection of Lung and Breast Cancer by Odor Signature

July 17, 2014 updated by: BioSense Medical LTD

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Breast Cancer patient after diagnosis. Lung Cancer patients after diagnosis. Healthy controls, matching gender and age.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy controls
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).
Lung cancer patients
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).
Breast Cancer patients
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Testing the ability of our biosensors to distinguish between different sub- types of breast and lung cancer.
Time Frame: 3 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BioSense Medical LTD

Collaborators

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

July 16, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (ESTIMATE)

July 21, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 21, 2014

Last Update Submitted That Met QC Criteria

July 17, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0695-13-SMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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