Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01292369
• Other study ID #: RMB-0566.CTIL
• Status: Recruiting
• Phase: N/A
• First received: February 6, 2011
• Last updated: August 17, 2011
• Start date: February 2011
• Est. completion date: December 2011

Study information

• Verified date: August 2011
• Source: Rambam Health Care Campus
• Contact: Zahava Galimidi, Dr.
• Phone: 972-4-8543684
• Email: z_gallimidi[@]rambam.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 560
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer

Locations

Country	Name	City	State
Israel	Carmel medical center	Haifa
Israel	RAMBAM medical center	Haifa

Sponsors (2)

Lead Sponsor	Collaborator
Rambam Health Care Campus	Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	System performance	Sensitivity and specificity of NaNose system in diagnosing cancer	10 months	No