Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01292369|
Recruitment Status : Unknown
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was: Recruiting
First Posted : February 9, 2011
Last Update Posted : August 18, 2011
|Condition or disease|
|Breast Cancer 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.
|Study Type :||Observational|
|Estimated Enrollment :||560 participants|
|Observational Model:||Case Control|
|Official Title:||Observational Study Aimed to Characterize a System for Breast and Colon Cancer Diagnosis by Breath Testing - NaNose Study|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||October 2011|
|Estimated Study Completion Date :||December 2011|
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.
- System performance [ Time Frame: 10 months ]Sensitivity and specificity of NaNose system in diagnosing cancer
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01292369
|Contact: Zahava Galimidi, Dr.||firstname.lastname@example.org|
|Contact: Yehuda Hovers, Prof.||email@example.com|
|RAMBAM medical center||Recruiting|
|Haifa, Israel, 31096|
|Contact: Zahava Galimidi, Dr. 972-4-8543684 firstname.lastname@example.org|
|Principal Investigator: Zahava Galimidi, Dr.|
|Sub-Investigator: Yehuda Hovers, Prof.|
|Carmel medical center||Not yet recruiting|
|Contact: Ori Segol, MD 04-8250356 email@example.com|
|Principal Investigator: Ori Segol, MD|