Breath Test to Predict Breast Cancer and Outcome of Mammography

Breast Cancer Clinical Trial

Official title:

Breath Test to Predict Breast Cancer and Outcome of Mammography

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04755829
• Other study ID #: M2020 UK01
• Status: Not yet recruiting
• Start date: March 2021
• Est. completion date: March 2023

Study information

• Verified date: February 2021
• Source: Menssana Research, Inc.
• Contact: Michael Phillips, MD
• Phone: 9732649825
• Email: mphillips[@]menssanaresearch.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: March 2023
• Est. primary completion date: March 2023
• Gender: Female
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Abnormal Mammogram, Unspecified
• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• BreathX test for breath VOCs
Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.

Locations

Country	Name	City	State
Germany	University of Erlangen	Erlangen
Netherlands	Zuyderland Medical Center	Heerlen
United Kingdom	Frimley Health NHS Foundation Trust	Middlesex

Sponsors (4)

Lead Sponsor	Collaborator
Menssana Research, Inc.	Mount Vernon Cancer Centre, University of Erlangen-Nürnberg, Zuyderland Medical Centre

Countries where clinical trial is conducted

Germany,  Netherlands,  United Kingdom, 

References & Publications (37)

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Brueggemeier RW, Díaz-Cruz ES. Relationship between aromatase and cyclooxygenases in breast cancer: potential for new therapeutic approaches. Minerva Endocrinol. 2006 Mar;31(1):13-26. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Hackshaw A. Benefits and harms of mammography screening. BMJ. 2012 Jan 6;344:d8279. doi: 10.1136/bmj.d8279. — View Citation

Health, United States, 2015. Centers for Disease Control and Prevention National Center for Health Statistics; 2015.

Heartsbreath - H030004. 2004. at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H030004.

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. — View Citation

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. Review. — View Citation

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. Review. Erratum in: Free Radic Biol Med 1994 Dec;17(6):609. — View Citation

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. Review. — View Citation

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. — View Citation

Montuschi P, Mores N, Trové 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 Apr 25. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: JAMA. 2004 Feb 18;291(7):824. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 37 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 years
Primary	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	2 years