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Status unknownNCT04755829Updated Feb 16, 2021

Breath Test to Predict Breast Cancer and Outcome of Mammography

An observational study in Breast Cancer and Abnormal Mammogram, Unspecified, sponsored by Menssana Research, Inc.. Status unknown at 3 sites in 3 countries. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-16.

Sponsored by Menssana Research, Inc. · Observational

The sponsor has not verified this record recently (last verified Feb 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
1,000
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Breast Cancer
  • Abnormal Mammogram, Unspecified

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Keywords

  • screening mammography
  • biomarker of breast disease
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Menssana Research, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Sampling method
Probability sample

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)

Eligibility criteria

Group 1: Normal screening mammogram

Inclusion Criteria:

  1. Female aged 18 years or older
  2. Understands the study, and is willing to give written informed consent to participate
  3. If a screening mammogram was performed during the preceding six month period, then the results were reported as normal (BIRADS 1 or 2)
  4. 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*.
  5. 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.

Exclusion Criteria:

  1. Previous history of an abnormal mammogram, breast disease, or breast biopsy
  2. Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
  3. Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
  4. Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
  5. General anesthesia during the 10-day period prior to breath collection.

Group 2: Abnormal screening mammogram

Inclusion Criteria:

Female aged 18 years or older

  1. Understands the study, and is willing to give written informed consent to participate
  2. Abnormal screening mammogram during preceding six months (BIRADS 3-6)
  3. 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-)

Exclusion criteria:

  1. Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
  2. Previous history of breast biopsy
  3. Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
  4. Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
  5. General anesthesia during the 10-day period prior to breath collection. -
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group 1

    Normal screening mammogram (BIRADS 1 or 2)

    Device: BreathX test for breath VOCs

  • Group 2

    Abnormal screening mammogram (BIRADS 3 to 6)

    Device: BreathX test for breath VOCs

Interventions

  • DeviceBreathX test for breath VOCs

    Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

  2. 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

    Time frame: 2 years

07

Study locations

3 sites
08

References and documents

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. Erratum In: JAMA. 2004 Feb 18;291(7):824. PubMed 14570948 ↗
  • Health, 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 17456866 ↗
  • White 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 25809209 ↗
  • Welch 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 24380095 ↗
  • Hackshaw A. Benefits and harms of mammography screening. BMJ. 2012 Jan 6;344:d8279. doi: 10.1136/bmj.d8279. No abstract available. PubMed 22228697 ↗
  • Kneepkens 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 1591898 ↗
  • Kneepkens 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. Erratum In: Free Radic Biol Med 1994 Dec;17(6):609. PubMed 7959173 ↗
  • Aghdassi 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 10802218 ↗
  • Spink 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 11854143 ↗
  • Brueggemeier 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 16498361 ↗
  • Phillips 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 24086492 ↗
  • Phillips 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 23793046 ↗
  • Qiao 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 24900994 ↗
  • Amann 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 ↗
  • Phillips M, Altorki N, Austin JH, Cameron RB, Cataneo RN, Greenberg J, Kloss R, Maxfield RA, Munawar MI, Pass HI, Rashid A, Rom WN, Schmitt P. Prediction of lung cancer using volatile biomarkers in breath. Cancer Biomark. 2007;3(2):95-109. doi: 10.3233/cbm-2007-3204. PubMed 17522431 ↗
  • D'Amico A, Pennazza G, Santonico M, Martinelli E, Roscioni C, Galluccio G, Paolesse R, Di Natale C. An investigation on electronic nose diagnosis of lung cancer. Lung Cancer. 2010 May;68(2):170-6. doi: 10.1016/j.lungcan.2009.11.003. Epub 2009 Dec 2. PubMed 19959252 ↗
  • Montuschi P, Mores N, Trove A, Mondino C, Barnes PJ. The electronic nose in respiratory medicine. Respiration. 2013;85(1):72-84. doi: 10.1159/000340044. Epub 2012 Sep 25. PubMed 23018197 ↗
  • Ehmann R, Boedeker E, Friedrich U, Sagert J, Dippon J, Friedel G, Walles T. Canine scent detection in the diagnosis of lung cancer: revisiting a puzzling phenomenon. Eur Respir J. 2012 Mar;39(3):669-76. doi: 10.1183/09031936.00051711. Epub 2011 Aug 18. PubMed 21852337 ↗
  • Boedeker E, Friedel G, Walles T. Sniffer dogs as part of a bimodal bionic research approach to develop a lung cancer screening. Interact Cardiovasc Thorac Surg. 2012 May;14(5):511-5. doi: 10.1093/icvts/ivr070. Epub 2012 Feb 17. PubMed 22345057 ↗
  • Vijverberg SJ, Hilvering B, Raaijmakers JA, Lammers JW, Maitland-van der Zee AH, Koenderman L. Clinical utility of asthma biomarkers: from bench to bedside. Biologics. 2013;7:199-210. doi: 10.2147/BTT.S29976. Epub 2013 Aug 29. PubMed 24009412 ↗
  • Phillips M, Gleeson K, Hughes JM, Greenberg J, Cataneo RN, Baker L, McVay WP. Volatile organic compounds in breath as markers of lung cancer: a cross-sectional study. Lancet. 1999 Jun 5;353(9168):1930-3. doi: 10.1016/S0140-6736(98)07552-7. PubMed 10371572 ↗
  • Phillips M, Cataneo RN, Cummin AR, Gagliardi AJ, Gleeson K, Greenberg J, Maxfield RA, Rom WN. Detection of lung cancer with volatile markers in the breath. Chest. 2003 Jun;123(6):2115-23. doi: 10.1378/chest.123.6.2115. PubMed 12796197 ↗
  • Phillips M, Altorki N, Austin JH, Cameron RB, Cataneo RN, Kloss R, Maxfield RA, Munawar MI, Pass HI, Rashid A, Rom WN, Schmitt P, Wai J. Detection of lung cancer using weighted digital analysis of breath biomarkers. Clin Chim Acta. 2008 Jul 17;393(2):76-84. doi: 10.1016/j.cca.2008.02.021. Epub 2008 Mar 3. PubMed 18420034 ↗
  • Phillips M, Cataneo RN, Condos R, Ring Erickson GA, Greenberg J, La Bombardi V, Munawar MI, Tietje O. Volatile biomarkers of pulmonary tuberculosis in the breath. Tuberculosis (Edinb). 2007 Jan;87(1):44-52. doi: 10.1016/j.tube.2006.03.004. Epub 2006 Apr 25. PubMed 16635588 ↗
  • Phillips M, Basa-Dalay V, Bothamley G, Cataneo RN, Lam PK, Natividad MP, Schmitt P, Wai J. Breath biomarkers of active pulmonary tuberculosis. Tuberculosis (Edinb). 2010 Mar;90(2):145-51. doi: 10.1016/j.tube.2010.01.003. Epub 2010 Feb 26. PubMed 20189456 ↗
  • Phillips M, Boehmer JP, Cataneo RN, Cheema T, Eisen HJ, Fallon JT, Fisher PE, Gass A, Greenberg J, Kobashigawa J, Mancini D, Rayburn B, Zucker MJ. Prediction of heart transplant rejection with a breath test for markers of oxidative stress. Am J Cardiol. 2004 Dec 15;94(12):1593-4. doi: 10.1016/j.amjcard.2004.08.052. PubMed 15589029 ↗
  • Ludviksdottir D, Diamant Z, Alving K, Bjermer L, Malinovschi A. Clinical aspects of using exhaled NO in asthma diagnosis and management. Clin Respir J. 2012 Oct;6(4):193-207. doi: 10.1111/crj.12001. PubMed 22898078 ↗
  • Elitsur Y, Tolia V, Gilger MA, Reeves-Garcia J, Schmidt-Sommerfeld E, Opekun AR, El-Zimaity H, Graham DY, Enmei K. Urea breath test in children: the United States prospective, multicenter study. Helicobacter. 2009 Apr;14(2):134-40. doi: 10.1111/j.1523-5378.2009.00670.x. PubMed 19298341 ↗
  • Heartsbreath - H030004. 2004. at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H030004.
  • Mathews JM, Raymer JH, Etheridge AS, Velez GR, Bucher JR. Do endogenous volatile organic chemicals measured in breath reflect and maintain CYP2E1 levels in vivo? Toxicol Appl Pharmacol. 1997 Oct;146(2):255-60. doi: 10.1006/taap.1997.8257. PubMed 9344893 ↗
  • Bulun SE, Lin Z, Zhao H, Lu M, Amin S, Reierstad S, Chen D. Regulation of aromatase expression in breast cancer tissue. Ann N Y Acad Sci. 2009 Feb;1155:121-31. doi: 10.1111/j.1749-6632.2009.03705.x. PubMed 19250199 ↗
  • Boots AW, van Berkel JJ, Dallinga JW, Smolinska A, Wouters EF, van Schooten FJ. The versatile use of exhaled volatile organic compounds in human health and disease. J Breath Res. 2012 Jun;6(2):027108. doi: 10.1088/1752-7155/6/2/027108. Epub 2012 May 23. PubMed 22621865 ↗
  • Phillips M, Beatty JD, Cataneo RN, Huston J, Kaplan PD, Lalisang RI, Lambin P, Lobbes MB, Mundada M, Pappas N, Patel U. Rapid point-of-care breath test for biomarkers of breast cancer and abnormal mammograms. PLoS One. 2014 Mar 5;9(3):e90226. doi: 10.1371/journal.pone.0090226. eCollection 2014. PubMed 24599224 ↗
  • Phillips M, inventor USPTO Application no. 20170188887. Ultra-clean bag or balloon for collection of volatile organic compounds in breath or air https://www.google.com/patents/US20170188887. USA2017.
  • Phillips M. Method for the collection and assay of volatile organic compounds in breath. Anal Biochem. 1997 May 1;247(2):272-8. doi: 10.1006/abio.1997.2069. PubMed 9177688 ↗
  • Phillips M, Herrera J, Krishnan S, Zain M, Greenberg J, Cataneo RN. Variation in volatile organic compounds in the breath of normal humans. J Chromatogr B Biomed Sci Appl. 1999 Jun 11;729(1-2):75-88. doi: 10.1016/s0378-4347(99)00127-9. PubMed 10410929 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 16, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04755829
Lead sponsor
Menssana Research, Inc.
Collaborators
Mount Vernon Cancer Centre, Zuyderland Medical Centre, University of Erlangen-Nürnberg
Responsible party
Sponsor
First posted
Feb 16, 2021
Start date
Mar 2021 (estimated)
Primary completion
Mar 2023 (estimated)
Completion
Mar 2023 (estimated)
Last update
Feb 16, 2021

Study contacts

Michael Phillips, MD
Contact
mphillips@menssanaresearch.com
9732649825
Jonah Phillips, MBA
Contact
jphillips@menssanaresearch.com
2012406676
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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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