Breath Testing for Breast and Colon Cancer Diagnosis- NaNose Study

NCT ID: NCT01292369

Last Updated: 2011-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

560 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Colon Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Breast cancer

Women diagnosed with breast cancer by a positive biopsy test after mammography.

No interventions assigned to this group

Breast control

Women with negative biopsy result done due to a suspicious mammography exam.

No interventions assigned to this group

Colon cancer

Men and women diagnosed with colon cancer by a positive colonoscopy and biopsy.

No interventions assigned to this group

Colon control

Men and women with negative colonoscopy and biopsy tested due to complaints indicating the possibility of colon cancer.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Technion, Israel Institute of Technology

OTHER

Sponsor Role collaborator

Rambam Health Care Campus

OTHER

Sponsor Role lead

Responsible Party

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AMIT- Alfred Mann institute in the technion

Locations

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RAMBAM medical center

Haifa, , Israel

Site Status RECRUITING

Carmel medical center

Haifa, , Israel

Site Status NOT_YET_RECRUITING

Countries

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Israel

Central Contacts

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Zahava Galimidi, Dr.

Role: CONTACT

972-4-8543684

Yehuda Hovers, Prof.

Role: CONTACT

972-4-8543608

Facility Contacts

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Zahava Galimidi, Dr.

Role: primary

972-4-8543684

Ori Segol, MD

Role: primary

04-8250356

Other Identifiers

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RMB-0566.CTIL

Identifier Type: -

Identifier Source: org_study_id

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