Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Technion, Israel Institute of Technology
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01292369
First received: February 6, 2011
Last updated: August 17, 2011
Last verified: August 2011
  Purpose

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
Breast Cancer
Colon Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • System performance [ Time Frame: 10 months ] [ Designated as safety issue: No ]
    Sensitivity and specificity of NaNose system in diagnosing cancer


Biospecimen Retention:   Samples Without DNA

Breath samples


Estimated Enrollment: 560
Study Start Date: February 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
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.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01292369

Contacts
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

Locations
Israel
Carmel medical center Not yet recruiting
Haifa, Israel
Contact: Ori Segol, MD    04-8250356    ori_segol@clalit.org.il   
Principal Investigator: Ori Segol, MD         
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.         
Sponsors and Collaborators
Rambam Health Care Campus
Technion, Israel Institute of Technology
  More Information

No publications provided

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
Study First Received: February 6, 2011
Last Updated: August 17, 2011
Health Authority: Israel: Ministry of Health

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

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

ClinicalTrials.gov processed this record on October 20, 2014