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Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

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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
Technion, Israel Institute of Technology
Information provided by:
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.

Condition or disease
Breast Cancer Colon Cancer

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 Type : Observational
Estimated Enrollment : 560 participants
Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Breast cancer
Women diagnosed with breast cancer by a positive biopsy test after mammography.
Breast control
Women with negative biopsy result done due to a suspicious mammography exam.
Colon cancer
Men and women diagnosed with colon cancer by a positive colonoscopy and biopsy.
Colon control
Men and women with negative colonoscopy and biopsy tested due to complaints indicating the possibility of colon cancer.

Primary Outcome Measures :
  1. System performance [ Time Frame: 10 months ]
    Sensitivity and specificity of NaNose system in diagnosing cancer

Biospecimen Retention:   Samples Without DNA
Breath samples

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Men and women coming for medical tests:

  1. Women coming for a breast biopsy following a suspicious breast imaging result.
  2. Men and women coming for a colonoscopy, reffered by their family physician, due to complaints indicating the possibility of colon cancer.

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.

Information from the National Library of Medicine

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. 972-4-8543684 z_gallimidi@rambam.health.gov.il
Contact: Yehuda Hovers, Prof. 972-4-8543608 y_chowers@rambam.health.gov.il

RAMBAM medical center Recruiting
Haifa, Israel, 31096
Contact: Zahava Galimidi, Dr.    972-4-8543684    z_gallimidi@rambam.health.gov.il   
Principal Investigator: Zahava Galimidi, Dr.         
Sub-Investigator: Yehuda Hovers, Prof.         
Carmel medical center Not yet recruiting
Haifa, Israel
Contact: Ori Segol, MD    04-8250356    ori_segol@clalit.org.il   
Principal Investigator: Ori Segol, MD         
Sponsors and Collaborators
Rambam Health Care Campus
Technion, Israel Institute of Technology

Responsible Party: NaNose LTD, AMIT- Alfred Mann institute in the technion
ClinicalTrials.gov Identifier: NCT01292369     History of Changes
Other Study ID Numbers: RMB-0566.CTIL
First Posted: February 9, 2011    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: August 2011

Keywords provided by Rambam Health Care Campus:
breath test
colon cancer
breast cancer

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases