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

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ClinicalTrials.gov Identifier: NCT01849328
Recruitment Status : Unknown
Verified November 2013 by Rauscher, Gregory E., M.D. PA.
Recruitment status was:  Recruiting
First Posted : May 8, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Breast Cancer

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Study Start Date : May 2013
Estimated Primary Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
Breast Cancer
Healthy



Primary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women with breast cancer, biopsy confirmed, ages above 18. vs. Healthy women without breast cancer.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849328


Contacts
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Contact: Jamie Ketas 201-894-3418 Jamie.Ketas@ehmc.com

Locations
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United States, New Jersey
Englewood Hospital and Medical Center Recruiting
Englewood, New Jersey, United States, 07631
Principal Investigator: Rosalyn Stahl, MD         
Sponsors and Collaborators
Rauscher, Gregory E., M.D. PA

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Responsible Party: Rauscher, Gregory E., M.D. PA
ClinicalTrials.gov Identifier: NCT01849328     History of Changes
Other Study ID Numbers: E-13-492
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: November 19, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases