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Testing Spectrosense EVA System for Detection of Breast Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air

NCT ID: NCT01849328

Last Updated: 2013-11-19

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

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Brief Summary

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Volatile Organic Compounds (VOC) in human breath are captured and analyzed by the Spectrosense EVA system, which is combination of a gas chromatography (GC) and software algorithm. The objective is to obtain a set or sets of VOC bio-markers that will provide the best discrimination between Breast Cancer sick population and healthy population. The gold standard for identifying sick/healthy population is biopsy proven breast cancer.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Breast Cancer

No interventions assigned to this group

Healthy

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age from 18 years old
* Breast cancer positive biopsy
* Before any treatment
* Signed Informed Patient Consent


* Healthy women
* No history of Breast cancer
* Signed Informed Patient Consent

Exclusion Criteria

* Age under 18 years old
* Neoadjovant treatment
* Post surgery for breast cancer
* A history of any other cancer type, except skin cancer that is not melanoma

Healthy group:


* History of Breast cancer
* Breast cancer background in the family
* A history of any other cancer type, except skin cancer that is not melanoma
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rauscher, Gregory E., M.D. PA

INDIV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Englewood Hospital and Medical Center

Englewood, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jamie Ketas

Role: CONTACT

Phone: 201-894-3418

Email: [email protected]

Other Identifiers

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E-13-492

Identifier Type: -

Identifier Source: org_study_id