Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

• Conditions: Colon Cancer; Breast Cancer

• Registration Number: NCT01292369
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-06
• Study First Submitted QC: 2011-02-08
• Study First Posted: 2011-02-09
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-17
• Last Update Posted: 2011-08-18
• Primary Completion: 2011-10
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 560

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
System performance	10 months	Sensitivity and specificity of NaNose system in diagnosing cancer

Trial Locations

Locations (2)

Carmel medical center; 🇮🇱 Haifa, Israel

RAMBAM medical center; 🇮🇱 Haifa, Israel