Non Invasive Detection of Lung and Breast Cancer by Odor Signature

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by BioSense Medical LTD
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
BioSense Medical LTD
ClinicalTrials.gov Identifier:
NCT02195076
First received: July 16, 2014
Last updated: July 17, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Lung Cancer
Breast Cancer
Other: non-invasive detection of cancer odor

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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

Resource links provided by NLM:


Further study details as provided by BioSense Medical LTD:

Primary Outcome Measures:
  • The sensitivity and specificity of our biosensors in lung and breast cancer detection [ Time Frame: 3 years ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Testing the ability of our biosensors to distinguish between different sub- types of breast and lung cancer. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA

urine samples and exhaled breath samples


Estimated Enrollment: 400
Study Start Date: July 2014
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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).
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).
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).

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02195076

Contacts
Contact: Michal Mark Danieli, PhD +972-4-7706816 Michal@biosensem.com
Contact: Asher Castiel, PhD +972-4-7706816 asher.castiel@biosensem.com

Locations
Israel
Sheba Medical Center Recruiting
Tel Hashomer, Ramat- Gan, Israel, 52621
Contact: Einav Gal-Yam, MD PhD       Einav.NiliGal-Yam@sheba.health.gov.il   
Contact: Yair Bar, MD       Yair.bar@sheba.health.gov.il   
Principal Investigator: Einav Gal- Yam, M.D Ph.D         
Sponsors and Collaborators
BioSense Medical LTD
Sheba Medical Center
  More Information

No publications provided

Responsible Party: BioSense Medical LTD
ClinicalTrials.gov Identifier: NCT02195076     History of Changes
Other Study ID Numbers: 0695-13-SMC
Study First Received: July 16, 2014
Last Updated: July 17, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by BioSense Medical LTD:
Lung cancer
Breast Cancer
Biosensors
Volatile Organic Compounds
Odor
Urine Sample
Exhaled Breath Samples

Additional relevant MeSH terms:
Lung Neoplasms
Breast Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014