Testing Spectrosense EVA System for Detection of Breast Cancer by Analyzing Volatile Organic Compounds (VOCs) in Exhaled Air
Conditions
Breast Cancer
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case Control, Time Perspective: Cross-Sectional
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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

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
Location
Englewood Hospital and Medical Center
Englewood, New Jersey, United States
Status: Recruiting
Start Date
May 2013
Sponsors
Rauscher, Gregory E., M.D. PA
Source
Rauscher, Gregory E., M.D. PA
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page