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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT02195076
Date of registration: 16/07/2014
Prospective Registration: No
Primary sponsor: BioSense Medical LTD
Public title: Non Invasive Detection of Lung and Breast Cancer by Odor Signature
Scientific 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
Date of first enrolment: July 2014
Target sample size: 400
Recruitment status: Recruiting
URL:  http://clinicaltrials.gov/show/NCT02195076
Study type:  Observational [Patient Registry]
Study design:  Observational Model: Case Control, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Israel
Contacts
Name:     Einav Gal-Yam, MD PhD
Address: 
Telephone:
Email: Einav.NiliGal-Yam@sheba.health.gov.il
Affiliation: 
Name:     Michal Mark Danieli, PhD
Address: 
Telephone: +972-4-7706816
Email: Michal@biosensem.com
Affiliation: 
Key inclusion & exclusion 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



Age minimum: 30 Years
Age maximum: 80 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Breast Cancer
Lung Cancer
Intervention(s)
Other: non-invasive detection of cancer odor
Primary Outcome(s)
The sensitivity and specificity of our biosensors in lung and breast cancer detection [Time Frame: 3 years]
Secondary Outcome(s)
Testing the ability of our biosensors to distinguish between different sub- types of breast and lung cancer. [Time Frame: 3 years]
Secondary ID(s)
0695-13-SMC
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Sheba Medical Center
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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