Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

Study Overview
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Brief Summary
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The concept of breath testing for various diseases has been around since ancient greece. It has been hypothesized that cancer is generating a unique pattern of compounds in patients' breath. This study is trying to characterize a novel system, based on nanoparticles technology, for cancer diagnosis through breath samples.

Detailed Description
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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.

Official Title
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Observational Study Aimed to Characterize a System for Breast and Colon Cancer Diagnosis by Breath Testing - NaNose Study

Conditions
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Breast Cancer, Colon Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women attending Rambam medical center for either breast biopsy or colonoscopy. Suspicious finding on breast imaging requiring a biopsy. Complaints indicating the possibility of colon cancer: Blood in stool, weight loss, constipation, anemia, family history of colon cancer. Exclusion Criteria: Other known active malignancy. History of malignant disease and treatments.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer<br>Women diagnosed with breast cancer by a positive biopsy test after mammography. | |
| Breast control<br>Women with negative biopsy result done due to a suspicious mammography exam. | |
| Colon cancer<br>Men and women diagnosed with colon cancer by a positive colonoscopy and biopsy. | |
| Colon control<br>Men and women with negative colonoscopy and biopsy tested due to complaints indicating the possibility of colon cancer. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System performance | Sensitivity and specificity of NaNose system in diagnosing cancer | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breath test, colon cancer, breast cancer