A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02888366|
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : October 29, 2018
|Condition or disease|
Clinical perspective on breath testing for breast cancer:
Breast cancer is the most commonly diagnosed cancer in women, in whom it is second only to lung cancer as a cause of cancer death. The National Cancer Institute estimated that more than 232,000 US women would be diagnosed with breast cancer in 2013 and nearly 40,000 would die of the disease.
Screening mammography and its limitations: In order to reduce the number of breast cancer deaths, many countries have established screening mammography programs to detect and treat early-stage disease. However, the impact of screening mammography on mortality has been questioned. Also, screening mammography is limited by its very low yield: a 2005 retrospective analysis reported that 510 US radiologists performed 2,289,132 screening mammograms and found 9,030 cancers i.e. only one cancer was found for every 253 mammograms. 99.6% of all screening mammograms were negative for cancer: they provided reassurance, but at a human cost of millions of women exposed to potentially hazardous radiation and discomfort, and a financial cost of several million dollars. Also, screening mammography may be associated with an increased risk of radiation-induced breast cancer, as well as with overdiagnosis and overtreatment. Many women decide not to take the test even when it is readily available, and screening mammography may be underutilized because of fear of pain and radiation exposure, ethnicity, poverty, and level of education.
Breath tests - a new diagnostic tool: Abnormal volatile organic compounds (VOCs) in breath have been identified in breast cancer. Breath VOC biomarkers have been reported in other disorders including bronchial asthma, lung cancer, active pulmonary tuberculosis, radiation exposure, and heart transplant rejection. The Food & Drug Administration (FDA) approved the nitric oxide breath test in bronchial asthma, the urea breath test for H. pylori, and Menssana Research's Heartsbreath test for heart transplant rejection under the Humanitarian Device Exemption regulations.
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer|
|Actual Study Start Date :||March 1, 2017|
|Actual Primary Completion Date :||August 30, 2018|
|Actual Study Completion Date :||August 30, 2018|
Breath samples taken, no treatment given.
- A PROSPECTIVE VALIDATION STUDY OF A RAPID POINT-OF-CARE BREATH TEST FOR BREAST CANCER [ Time Frame: 2 years ]Change in sensitivity and specificity of mammography for breast cancer when combined with results of breath test.
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): NCT02888366
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, New Jersey|
|Hackensack Medical Center, Mountainside Hospital|
|Montclair, New Jersey, United States, 07042|
|St. Michael's Medical Center|
|Newark, New Jersey, United States, 07102|
|United States, Texas|
|MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Phillips, MD||Menssana Research, Inc.|