Breast CancerNCT04755829
Breath Test to Predict Breast Cancer and Outcome of Mammography
An observational study of Breast Cancer and Abnormal Mammogram, Unspecified, run by Menssana Research, Inc. at 3 sites in 3 countries.
Trial summary
To validate a breath test that predicts risk of breast cancer and an abnormal mammogram. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Abnormal Mammogram, Unspecified
- What is being tested?
- BreathX test for breath VOCs
- Type of treatment
- Medical device
- How many people
- 1,000 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Mar 2021to Mar 2023
- 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
- Adult, Older adult
Study population: Phase 1 Model-building phase (unblinded) Subjects will be enrolled in two groups: Group 1. Normal screening mammogram (BIRADS 1 or 2) Group 2. Abnormal screening mammogram (BIRADS 3 to 6) Phase 2 Model-testing phase (blinded) Subjects will be enrolled in two groups: Group 3. Normal screening mammogram (BIRADS 1 or 2) Group 4. Abnormal screening mammogram (BIRADS 3 to 6)
Who may be able to join
- Female aged 18 years or older
- Understands the study, and is willing to give written informed consent to participate
- If a screening mammogram was performed during the preceding six month period, then the results were reported as normal (BIRADS 1 or 2)
- If a screening mammogram was not performed during the preceding six month period, then approves collection of the results of a screening mammogram if and when it is performed subsequently*.
- Approves collection of relevant additional data for clinical research record if and when these data become available, including results of imaging studies, breast biopsy, and other relevant biomarker data e.g. status of BRCA1, BRCA2, HER2 and receptors (ER+ or ER-) and progesterone (PgR+ or PgR-) * If a subsequent screening mammogram is reported as abnormal, the subject will be transferred to Group 2 for analysis of data.
- Female aged 18 years or older
Show all 9Show fewer
- Understands the study, and is willing to give written informed consent to participate
- Abnormal screening mammogram during preceding six months (BIRADS 3-6)
- Approves collection of relevant additional data for clinical research record if and when it becomes available, including results of imaging studies, biopsy results, 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
- Previous history of an abnormal mammogram, breast disease, or breast biopsy
- Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
- Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
- Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
- General anesthesia during the 10-day period prior to breath collection.
- Group 2: Abnormal screening mammogram
Show all 11Show fewer
- Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
- Previous history of breast biopsy
- Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
- Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
- General anesthesia during the 10-day period prior to breath collection. -
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
University of Erlangen
Erlangen
Peter Fasching, MD, Peter.Fasching@uk-erlangen.de
Hanna Huebner, Hanna.Huebner@uk-erlangen.de
Netherlands1 site
Zuyderland Medical Center
Heerlen
Marc Lobbes, MD, mbi.lobbes@gmail.com
United Kingdom1 site
Frimley Health NHS Foundation Trust
Middlesex, HA6 2RN
Alexandra Tenovici, MD, 44 020 3826 2537, alexandra.tenovici@nhs.net
About this study
To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.
Read the detailed description
We will determine the accuracy of volatile organic compounds (VOCs) in the breath as predictors of risk of breast cancer and an abnormal mammogram. Breath samples will be collected using an ultra-clean collection bag and analyzed with gas chromatography surface acoustic wave detection (GC SAW)
The study will be performed in two phases:
Phase 1: Model-building phase (cross-sectional study): Breath VOCs will be employed to construct multivariate algorithms that distinguish between normal women and those with breast cancer and abnormal screening mammograms.
Phase 2: Model-testing phase (cross-sectional study): The predictive accuracy of these algorithms will be tested to predict outcomes in normal women and those with breast cancer and abnormal screening mammograms.
- Conditions
- Breast Cancer, Abnormal Mammogram, Unspecified
- Being tested
- BreathX test for breath VOCs
- Keywords
- screening mammography, biomarker of breast disease
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreathX test for breath VOCsDevice
Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Normal screening mammogram (BIRADS 1 or 2) Receives: Device: BreathX test for breath VOCs | |
| Group 2 | Abnormal screening mammogram (BIRADS 3 to 6) Receives: Device: BreathX test for breath VOCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
BREATH TEST TO PREDICT BREAST CANCER
Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an abnormal mammogram.
Measured: 2 years
BREATH TEST TO PREDICT OUTCOME OF MAMMOGRAPHY
Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an biopsy-proven breast cancer
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 posted16 Feb 2021
- Study startMar 2021 (estimated)
- Primary completionMar 2023 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menssana Research, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Mount Vernon Cancer Centre, Zuyderland Medical Centre, University of Erlangen-Nürnberg
- Responsible party
- Sponsor
- Investigators
- Alexandra Tenovici, Principal investigator, Frimley Health NHS Foundation TrustMarc Lobbes, MD, Principal investigator, Zuyderland Medical CenterPeter Fasching, MD, Principal investigator, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04755829
- Sponsor's protocol ID
- M2020 UK01
- Status last verified
- Feb 2021
- First submitted
- 8 Feb 2021
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith-Bindman R, Chu PW, Miglioretti DL, Sickles EA, Blanks R, Ballard-Barbash R, Bobo JK, Lee NC, Wallis MG, Patnick J, Kerlikowske K. Comparison of screening mammography in the United States and the United kingdom. JAMA. 2003 Oct 22;290(16):2129-37. doi: 10.1001/jama.290.16.2129.
PubMed 14570948Health, United States, 2015. Centers for Disease Control and Prevention National Center for Health Statistics; 2015.
Jiang Y, Miglioretti DL, Metz CE, Schmidt RA. Breast cancer detection rate: designing imaging trials to demonstrate improvements. Radiology. 2007 May;243(2):360-7. doi: 10.1148/radiol.2432060253.
PubMed 17456866White A, Miller J, Royalty J, Ryerson AB, Benard V, Helsel W, Kammerer W. Clinical outcomes of mammography in the National Breast and Cervical Cancer Early Detection Program, 2009-2012. Cancer Causes Control. 2015 May;26(5):723-32. doi: 10.1007/s10552-015-0567-7. Epub 2015 Mar 26.
PubMed 25809209Welch HG, Passow HJ. Quantifying the benefits and harms of screening mammography. JAMA Intern Med. 2014 Mar;174(3):448-54. doi: 10.1001/jamainternmed.2013.13635.
PubMed 24380095Hackshaw A. Benefits and harms of mammography screening. BMJ. 2012 Jan 6;344:d8279. doi: 10.1136/bmj.d8279. No abstract available.
PubMed 22228697Kneepkens CM, Ferreira C, Lepage G, Roy CC. The hydrocarbon breath test in the study of lipid peroxidation: principles and practice. Clin Invest Med. 1992 Apr;15(2):163-86.
PubMed 1591898Kneepkens CM, Lepage G, Roy CC. The potential of the hydrocarbon breath test as a measure of lipid peroxidation. Free Radic Biol Med. 1994 Aug;17(2):127-60. doi: 10.1016/0891-5849(94)90110-4.
PubMed 7959173Aghdassi E, Allard JP. Breath alkanes as a marker of oxidative stress in different clinical conditions. Free Radic Biol Med. 2000 Mar 15;28(6):880-6. doi: 10.1016/s0891-5849(00)00189-1.
PubMed 10802218Spink DC, Katz BH, Hussain MM, Spink BC, Wu SJ, Liu N, Pause R, Kaminsky LS. Induction of CYP1A1 and CYP1B1 in T-47D human breast cancer cells by benzo[a]pyrene is diminished by arsenite. Drug Metab Dispos. 2002 Mar;30(3):262-9. doi: 10.1124/dmd.30.3.262.
PubMed 11854143Brueggemeier RW, Diaz-Cruz ES. Relationship between aromatase and cyclooxygenases in breast cancer: potential for new therapeutic approaches. Minerva Endocrinol. 2006 Mar;31(1):13-26.
PubMed 16498361Phillips M, Cataneo RN, Chaturvedi A, Kaplan PD, Libardoni M, Mundada M, Patel U, Zhang X. Detection of an extended human volatome with comprehensive two-dimensional gas chromatography time-of-flight mass spectrometry. PLoS One. 2013 Sep 25;8(9):e75274. doi: 10.1371/journal.pone.0075274. eCollection 2013.
PubMed 24086492Phillips M, Byrnes R, Cataneo RN, Chaturvedi A, Kaplan PD, Libardoni M, Mehta V, Mundada M, Patel U, Ramakrishna N, Schiff PB, Zhang X. Detection of volatile biomarkers of therapeutic radiation in breath. J Breath Res. 2013 Sep;7(3):036002. doi: 10.1088/1752-7155/7/3/036002. Epub 2013 Jun 24.
PubMed 23793046Qiao Y, Gao Z, Liu Y, Cheng Y, Yu M, Zhao L, Duan Y, Liu Y. Breath ketone testing: a new biomarker for diagnosis and therapeutic monitoring of diabetic ketosis. Biomed Res Int. 2014;2014:869186. doi: 10.1155/2014/869186. Epub 2014 May 11.
PubMed 24900994Amann A, Corradi M, Mazzone P, Mutti A. Lung cancer biomarkers in exhaled breath. Expert Rev Mol Diagn. 2011 Mar;11(2):207-17. doi: 10.1586/erm.10.112.
PubMed 21405971
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breath Test to Predict Breast Cancer and Outcome of Mammography
- ClinicalTrials.gov ID
- NCT04755829
- Acronym / sponsor ID
- M2020 UK01
- Conditions
- Breast Cancer, Abnormal Mammogram, Unspecified
- Keywords
- screening mammography, biomarker of breast disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Menssana Research, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Mount Vernon Cancer Centre, Zuyderland Medical Centre, University of Erlangen-Nürnberg
- Study start
- Mar 2021 (estimated)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 16 Feb 2021 (actual)
- 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.
To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.
Detailed description
We will determine the accuracy of volatile organic compounds (VOCs) in the breath as predictors of risk of breast cancer and an abnormal mammogram. Breath samples will be collected using an ultra-clean collection bag and analyzed with gas chromatography surface acoustic wave detection (GC SAW)
The study will be performed in two phases:
Phase 1: Model-building phase (cross-sectional study): Breath VOCs will be employed to construct multivariate algorithms that distinguish between normal women and those with breast cancer and abnormal screening mammograms.
Phase 2: Model-testing phase (cross-sectional study): The predictive accuracy of these algorithms will be tested to predict outcomes in normal women and those with breast cancer and abnormal screening mammograms.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Device: BreathX test for breath VOCsNormal screening mammogram (BIRADS 1 or 2) |
| Group 2 | – | Device: BreathX test for breath VOCsAbnormal screening mammogram (BIRADS 3 to 6) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Phase 1 Model-building phase (unblinded) Subjects will be enrolled in two groups: Group 1. Normal screening mammogram (BIRADS 1 or 2) Group 2. Abnormal screening mammogram (BIRADS 3 to 6) Phase 2 Model-testing phase (blinded) Subjects will be enrolled in two groups: Group 3. Normal screening mammogram (BIRADS 1 or 2) Group 4. Abnormal screening mammogram (BIRADS 3 to 6)
Key inclusion criteria (9 listed)
- Female aged 18 years or older
- Understands the study, and is willing to give written informed consent to participate
- If a screening mammogram was performed during the preceding six month period, then the results were reported as normal (BIRADS 1 or 2)
- If a screening mammogram was not performed during the preceding six month period, then approves collection of the results of a screening mammogram if and when it is performed subsequently*.
- Approves collection of relevant additional data for clinical research record if and when these data become available, including results of imaging studies, breast biopsy, and other relevant biomarker data e.g. status of BRCA1, BRCA2, HER2 and receptors (ER+ or ER-) and progesterone (PgR+ or PgR-) * If a subsequent screening mammogram is reported as abnormal, the subject will be transferred to Group 2 for analysis of data.
Key exclusion criteria (11 listed)
- Previous history of an abnormal mammogram, breast disease, or breast biopsy
- Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
- Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
- Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
- General anesthesia during the 10-day period prior to breath collection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BreathX test for breath VOCsBreath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW. | Device | Group 1, Group 2 |
Primary outcome
BREATH TEST TO PREDICT BREAST CANCER
Time frame: 2 years
Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an abnormal mammogram.
BREATH TEST TO PREDICT OUTCOME OF MAMMOGRAPHY
Time frame: 2 years
Determination of the sensitivity, specificity, and positive and negative predictive values of a breath test for biomarkers that predict the risk of an biopsy-proven breast cancer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2021.
- Background: PubMed 14570948Smith-Bindman R, Chu PW, Miglioretti DL, Sickles EA, Blanks R, Ballard-Barbash R, Bobo JK, Lee NC, Wallis MG, Patnick J, Kerlikowske K. Comparison of screening mammography in the United States and the United kingdom. JAMA. 2003 Oct 22;290(16):2129-37. doi: 10.1001/jama.290.16.2129.
- BackgroundHealth, United States, 2015. Centers for Disease Control and Prevention National Center for Health Statistics; 2015.
- Background: PubMed 17456866Jiang Y, Miglioretti DL, Metz CE, Schmidt RA. Breast cancer detection rate: designing imaging trials to demonstrate improvements. Radiology. 2007 May;243(2):360-7. doi: 10.1148/radiol.2432060253.
- Background: PubMed 25809209White A, Miller J, Royalty J, Ryerson AB, Benard V, Helsel W, Kammerer W. Clinical outcomes of mammography in the National Breast and Cervical Cancer Early Detection Program, 2009-2012. Cancer Causes Control. 2015 May;26(5):723-32. doi: 10.1007/s10552-015-0567-7. Epub 2015 Mar 26.
- Background: PubMed 24380095Welch HG, Passow HJ. Quantifying the benefits and harms of screening mammography. JAMA Intern Med. 2014 Mar;174(3):448-54. doi: 10.1001/jamainternmed.2013.13635.
- Background: PubMed 22228697Hackshaw A. Benefits and harms of mammography screening. BMJ. 2012 Jan 6;344:d8279. doi: 10.1136/bmj.d8279. No abstract available.
- Background: PubMed 1591898Kneepkens CM, Ferreira C, Lepage G, Roy CC. The hydrocarbon breath test in the study of lipid peroxidation: principles and practice. Clin Invest Med. 1992 Apr;15(2):163-86.
- Background: PubMed 7959173Kneepkens CM, Lepage G, Roy CC. The potential of the hydrocarbon breath test as a measure of lipid peroxidation. Free Radic Biol Med. 1994 Aug;17(2):127-60. doi: 10.1016/0891-5849(94)90110-4.
- Background: PubMed 10802218Aghdassi E, Allard JP. Breath alkanes as a marker of oxidative stress in different clinical conditions. Free Radic Biol Med. 2000 Mar 15;28(6):880-6. doi: 10.1016/s0891-5849(00)00189-1.
- Background: PubMed 11854143Spink DC, Katz BH, Hussain MM, Spink BC, Wu SJ, Liu N, Pause R, Kaminsky LS. Induction of CYP1A1 and CYP1B1 in T-47D human breast cancer cells by benzo[a]pyrene is diminished by arsenite. Drug Metab Dispos. 2002 Mar;30(3):262-9. doi: 10.1124/dmd.30.3.262.
- Background: PubMed 16498361Brueggemeier RW, Diaz-Cruz ES. Relationship between aromatase and cyclooxygenases in breast cancer: potential for new therapeutic approaches. Minerva Endocrinol. 2006 Mar;31(1):13-26.
- Background: PubMed 24086492Phillips M, Cataneo RN, Chaturvedi A, Kaplan PD, Libardoni M, Mundada M, Patel U, Zhang X. Detection of an extended human volatome with comprehensive two-dimensional gas chromatography time-of-flight mass spectrometry. PLoS One. 2013 Sep 25;8(9):e75274. doi: 10.1371/journal.pone.0075274. eCollection 2013.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Alexandra Tenovici principal investigator
Frimley Health NHS Foundation Trust
Marc Lobbes, MD principal investigator
Zuyderland Medical Center
Peter Fasching, MD principal investigator
University of Erlangen-Nürnberg
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Abnormal Mammogram, Unspecified, run by Menssana Research, Inc. at 3 sites in 3 countries.
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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 16 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Netherlands, United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Phillips, MD (9732649825, mphillips@menssanaresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BREATH TEST TO PREDICT BREAST CANCER (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04755829, which also lists 37 linked publications.
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 16 Feb 2021.