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


N/A
50 Years
90 Years
Open (Enrolling)
Both
Breast Cancer, Colon Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Case Control, Time Perspective: Prospective

Outcome Measure:

System performance

Outcome Description:

Sensitivity and specificity of NaNose system in diagnosing cancer

Outcome Time Frame:

10 months

Safety Issue:

No

Authority:

Israel: Ministry of Health

Study ID:

RMB-0566.CTIL

NCT ID:

NCT01292369

Start Date:

February 2011

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Colon Cancer
  • breath test
  • colon cancer
  • breast cancer
  • Breast Neoplasms
  • Colonic Neoplasms

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