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

Rauscher, Gregory E., M.D. PA

Status: Unknown

Conditions: Breast Cancer

Study type: Observational

Identifiers

NCT01849328

E-13-492

Details and patient eligibility

About

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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

600 participants in 2 patient groups

Breast Cancer

Healthy