Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01292369

Enrollment

560

Registered

2011-02-09

Start date

2011-02-28

Completion date

2011-12-31

Last updated

2011-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Colon Cancer

Keywords

breath test, colon cancer, breast cancer

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 90 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
System performance	10 months	Sensitivity and specificity of NaNose system in diagnosing cancer

Countries

Israel

Contacts

Primary ContactZahava Galimidi, Dr.

z_gallimidi@rambam.health.gov.il972-4-8543684

Backup ContactYehuda Hovers, Prof.

y_chowers@rambam.health.gov.il972-4-8543608

Outcome results