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

November 18, 2013 updated by: Rauscher, Gregory E., M.D. PA
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Englewood, New Jersey, United States, 07631
        • Recruiting
        • Englewood Hospital and Medical Center
        • Principal Investigator:
          • Rosalyn Stahl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with breast cancer, biopsy confirmed, ages above 18. vs. Healthy women without breast cancer.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Breast Cancer
Healthy

What is the study measuring?

Primary Outcome Measures

Outcome 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.
Time Frame: Upon enrollment.
Upon enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rauscher, Gregory E., M.D. PA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

May 3, 2013

First Submitted That Met QC Criteria

May 5, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

November 19, 2013

Last Update Submitted That Met QC Criteria

November 18, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-13-492

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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