We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02888366
Previous Study | Return to List | Next Study

A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02888366
Recruitment Status : Completed
First Posted : September 5, 2016
Last Update Posted : October 29, 2018
University of Southern California
M.D. Anderson Cancer Center
Hackensack Meridian Health
St. Michael's Medical Center
Information provided by (Responsible Party):
Menssana Research, Inc.

Brief Summary:
This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for breast -related symptoms or signs. Breath tests will be performed in order to demonstrate that the outcome of mammography results combined with breast test results improves clinical sensitivity and specificity in a group that has an increased prior probability of cancer. Breath will be collected and analyzed with a rapid point-of-care instrument (BreathLink™) and also with a laboratory-based assay of samples collected into an inflatable bag (BreathBag™).

Condition or disease
Breast Cancer

Detailed Description:


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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Breath samples taken, no treatment given.

Primary Outcome Measures :
    Change in sensitivity and specificity of mammography for breast cancer when combined with results of breath test.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
2,000 women undergoing diagnostic mammography for breast-related symptoms or signs.

Inclusion Criteria:

  1. Female aged 18 years or over
  2. Referred for mammography for a breast-related concern (e.g. breast mass, nipple discharge etc.)
  3. Understands the study, and is willing to give written informed consent to participate
  4. Approves collection of relevant additional data for clinical research record if and when it becomes available, including results of mammogram and any other imaging studies, biopsy results, TNM staging, and other relevant biomarker data e.g. status of BRCA1, BRCA2, HER2 and receptors (ER+ or ER-) and progesterone (PgR+ or PgR-)

Exclusion Criteria:

  1. Known serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
  2. Previous history of treated breast cancer, or cancer of any other site, with the exception of basal cell carcinoma of skin.

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): NCT02888366

Layout table for location information
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
Sponsors and Collaborators
Menssana Research, Inc.
University of Southern California
M.D. Anderson Cancer Center
Hackensack Meridian Health
St. Michael's Medical Center
Layout table for investigator information
Principal Investigator: Michael Phillips, MD Menssana Research, Inc.
Layout table for additonal information
Responsible Party: Menssana Research, Inc.
ClinicalTrials.gov Identifier: NCT02888366    
Other Study ID Numbers: MR2016-03
First Posted: September 5, 2016    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Menssana Research, Inc.:
breast cancer
breath test
Rapid Point-of-care
Inflatable Bag
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases