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

• Conditions: Breast Cancer

• Registration Number: NCT01849328
• Lead Sponsor: Rauscher, Gregory E., M.D. PA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-03
• Study First Submitted QC: 2013-05-05
• Study First Posted: 2013-05-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-18
• Last Update Posted: 2013-11-19
• Primary Completion: 2014-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

Exclusion Criteria:

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Englewood Hospital and Medical Center; 🇺🇸 Englewood, New Jersey, United States