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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01849328

Enrollment

600

Registered

2013-05-08

Start date

2013-05-31

Completion date

Unknown

Last updated

2013-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Breast Cancer group: Inclusion Criteria: * Age from 18 years old * Breast cancer positive biopsy * Before any treatment * 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: Inclusion Criteria: * Healthy women * No history of Breast cancer * Signed Informed Patient Consent

Design outcomes

Primary

Measure	Time frame
Obtaining a set or sets of VOC bio-markers that will provide the best discrimination between Breast Cancer sick population and healthy population. breast cancer.	Upon enrollment.

Countries

United States

Contacts

Primary ContactJamie Ketas

Jamie.Ketas@ehmc.com201-894-3418

Outcome results