Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study
Recruitment status was: Recruiting
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Observational Study Aimed to Characterize a System for Breast and Colon Cancer Diagnosis by Breath Testing - NaNose Study|
- System performance [ Time Frame: 10 months ] [ Designated as safety issue: No ]Sensitivity and specificity of NaNose system in diagnosing cancer
Biospecimen Retention: Samples Without DNA
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||December 2011|
|Estimated Primary Completion Date:||October 2011 (Final data collection date for primary outcome measure)|
Women diagnosed with breast cancer by a positive biopsy test after mammography.
Women with negative biopsy result done due to a suspicious mammography exam.
Men and women diagnosed with colon cancer by a positive colonoscopy and biopsy.
Men and women with negative colonoscopy and biopsy tested due to complaints indicating the possibility of colon cancer.
Cancer is accompanied by increased oxidative stress and induction of polymorphic cytochrome P- 450 mixed oxidase enzymes (CYP). Both processes affect the abundance of volatile organic compounds (VOCs) in the breath because oxidative stress causes lipid peroxidation of polyunsaturated fatty acids in membranes, producing alkanes and methylalkanes which are catabolized by CYP.
In the Technion labs, a new system for breath samples diagnosis, is being developed. The system is based on Nanoparticles technology.
The current study will try to identify colon and breast cancer patients through their breath samples and discriminate them from healthy individuals.
Men and women coming for colonoscopy or breast biopsy will be recruited for the study. Breath samples will be taken from all volunteers before the medical test. Subjects with positive cancer results by biopsy will be the test groups for both diseases, all others will be the control.
The research goal is to test the NaNose system ability to discriminate between healthy and sick.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01292369
|RAMBAM medical center|
|Haifa, Israel, 31096|
|Carmel medical center|