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

This study is currently recruiting participants.
Verified April 2017 by Menssana Research, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02888366
First Posted: September 5, 2016
Last Update Posted: April 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborators:
University of Southern California
M.D. Anderson Cancer Center
Hackensack University Medical Center
St. Michael's Medical Center
Information provided by (Responsible Party):
Menssana Research, Inc.
  Purpose
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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer

Resource links provided by NLM:


Further study details as provided by Menssana Research, Inc.:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 2000
Actual Study Start Date: March 1, 2017
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Breath samples taken, no treatment given.

Detailed Description:

Introduction

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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.
  Contacts and Locations
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


Contacts
Contact: Michael Phillips, MD 9736435464 mphillips@menssanaresearch.com
Contact: Robert Schiff, PhD 9732271830 rschiff13@aol.com

Locations
United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90033
Contact: Linda Larsen, MD (PI)    323-865-3203    lhlarsen@med.usc.edu   
Contact: Sona Devedjian, Coordinator    323-865-3203    Sona.Devedjian@med.usc.edu   
United States, New Jersey
Hackensack Medical Center, Mountainside Hospital Not yet recruiting
Montclair, New Jersey, United States, 07042
Contact: Jan Pryor, MD (PI)    973-259-3505    janhuston@aol.com   
Contact: Christopher Cannara, Coordinator    973-429-6902    Christopher.Cannara@mountainsidehosp.com   
St. Michael's Medical Center Not yet recruiting
Newark, New Jersey, United States, 07102
Contact: Nadine Pappas-Wilkes, MD, PI    973-877-4127    npappas-wilkes@primehealthcare.com   
Contact: Herbery Galang, Coordinator    973-877-2735    hgalang@primehealthcare.com   
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Terese Bevers, MD (PI)    713-745-8048    tbevers@mdanderson.org   
Contact: Diane Weber, Coordinator    713-563-5752    DWeber@mdanderson.org   
Sponsors and Collaborators
Menssana Research, Inc.
University of Southern California
M.D. Anderson Cancer Center
Hackensack University Medical Center
St. Michael's Medical Center
Investigators
Principal Investigator: Michael Phillips, MD Menssana Research, Inc.
  More Information

Responsible Party: Menssana Research, Inc.
ClinicalTrials.gov Identifier: NCT02888366     History of Changes
Other Study ID Numbers: MR2016-03
First Submitted: August 22, 2016
First Posted: September 5, 2016
Last Update Posted: April 17, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Menssana Research, Inc.:
breast cancer
breath test
Menssana
Ancillary
Mammography
Rapid Point-of-care
Inflatable Bag

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