Breast CancerNCT02888366
A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer
An observational study of Breast Cancer, run by Menssana Research, Inc. at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 500 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Mar 2017to 30 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: 2,000 women undergoing diagnostic mammography for breast-related symptoms or signs.
Who may be able to join
- Female aged 18 years or over
- Referred for mammography for a breast-related concern (e.g. breast mass, nipple discharge etc.)
- Understands the study, and is willing to give written informed consent to participate
- 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-)
Who cannot join
- Known serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
- Previous history of treated breast cancer, or cancer of any other site, with the exception of basal cell carcinoma of skin.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
MD Anderson Cancer Center
Houston, Texas, 77030
University of Southern California
Los Angeles, California, 90033
Hackensack Medical Center, Mountainside Hospital
Montclair, New Jersey, 07042
St. Michael's Medical Center
Newark, New Jersey, 07102
About this study
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™).
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breath test, Menssana, Ancillary, Mammography, Rapid Point-of-care, Inflatable Bag
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Breath samples taken, no treatment given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
A PROSPECTIVE VALIDATION STUDY OF A RAPID POINT-OF-CARE BREATH TEST FOR BREAST CANCER
Change in sensitivity and specificity of mammography for breast cancer when combined with results of breath test.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start1 Mar 2017
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menssana Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California, M.D. Anderson Cancer Center, Hackensack Meridian Health, St. Michael's Medical Center
- Responsible party
- Sponsor
- Investigators
- Michael Phillips, MD, Principal investigator, Menssana Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888366
- Sponsor's protocol ID
- MR2016-03
- Status last verified
- Oct 2018
- First submitted
- 22 Aug 2016
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer
- ClinicalTrials.gov ID
- NCT02888366
- Acronym / sponsor ID
- MR2016-03
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breath test, Menssana, Ancillary, Mammography, Rapid Point-of-care, Inflatable Bag
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Menssana Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California, M.D. Anderson Cancer Center, Hackensack Meridian Health, St. Michael's Medical Center
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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™).
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Breath samples taken, no treatment given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 2,000 women undergoing diagnostic mammography for breast-related symptoms or signs.
Key inclusion criteria (4 listed)
- Female aged 18 years or over
- Referred for mammography for a breast-related concern (e.g. breast mass, nipple discharge etc.)
- Understands the study, and is willing to give written informed consent to participate
- 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-)
Key exclusion criteria (2 listed)
- Known serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
- Previous history of treated breast cancer, or cancer of any other site, with the exception of basal cell carcinoma of skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Phillips, MD principal investigator
Menssana Research, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Menssana Research, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A PROSPECTIVE VALIDATION STUDY OF A RAPID POINT-OF-CARE BREATH TEST FOR BREAST CANCER (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2018.