Non Invasive Detection of Lung and Breast Cancer by Odor Signature
A Clinical Study Design to Evaluate the Specificity and Sensitivity of Our Novel System for Detection of Breast and Lung Cancer by Odor Signature
1 other identifier
observational
400
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 16, 2014
CompletedFirst Posted
Study publicly available on registry
July 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedJuly 21, 2014
July 1, 2014
3 years
July 16, 2014
July 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Testing the ability of our biosensors to distinguish between different sub- types of breast and lung cancer.
3 years
Study Arms (3)
Breast Cancer patients
Lung cancer patients
Healthy controls
Interventions
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).
Eligibility Criteria
Breast Cancer patient after diagnosis. Lung Cancer patients after diagnosis. Healthy controls, matching gender and age.
You may qualify if:
- Diagnosed Lung Cancer patients
- Diagnosed Breast Cancer patients
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BioSense Medical LTDlead
- Sheba Medical Centercollaborator
Study Sites (1)
Sheba Medical Center
Tel Hashomer, Ramat- Gan, 52621, Israel
Biospecimen
urine samples and exhaled breath samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 16, 2014
First Posted
July 21, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2017
Last Updated
July 21, 2014
Record last verified: 2014-07