Breath Test to Predict Breast Cancer and Outcome of Mammography
NCT ID: NCT04755829
Last Updated: 2021-02-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Total Enrollment
1000 participants
Study Classification
OBSERVATIONAL
Study Start Date
2021-03-31
Study Completion Date
2023-03-31
Brief Summary
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To validate a breath test that predicts risk of breast cancer and an abnormal mammogram.
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Detailed Description
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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.
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
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Breast Cancer
Abnormal Mammogram, Unspecified
Study Design
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Observational Model Type
OTHER
Study Time Perspective
CROSS_SECTIONAL
Study Groups
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Group 1
Normal screening mammogram (BIRADS 1 or 2)
BreathX test for breath VOCs
Intervention Type
DEVICE
Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.
Group 2
Abnormal screening mammogram (BIRADS 3 to 6)
BreathX test for breath VOCs
Intervention Type
DEVICE
Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.
Interventions
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BreathX test for breath VOCs
Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.
Intervention Type
DEVICE
Eligibility Criteria
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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.
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-)
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.
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 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
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. -
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
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. -
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Mount Vernon Cancer Centre
UNKNOWN
Sponsor Role
collaborator
Zuyderland Medical Centre
OTHER
Sponsor Role
collaborator
University of Erlangen-Nürnberg
OTHER
Sponsor Role
collaborator
Menssana Research, Inc.
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Alexandra Tenovici
Role: PRINCIPAL_INVESTIGATOR
Frimley Health NHS Foundation Trust
Marc Lobbes, MD
Role: PRINCIPAL_INVESTIGATOR
Zuyderland Medical Center
Peter Fasching, MD
Role: PRINCIPAL_INVESTIGATOR
University of Erlangen-Nürnberg
Locations
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University of Erlangen
Erlangen, , Germany
Site Status
Zuyderland Medical Center
Heerlen, , Netherlands
Site Status
Frimley Health NHS Foundation Trust
Middlesex, , United Kingdom
Site Status
Countries
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Germany
Netherlands
United Kingdom
Central Contacts
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Facility Contacts
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References
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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.
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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.
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Hackshaw A. Benefits and harms of mammography screening. BMJ. 2012 Jan 6;344:d8279. doi: 10.1136/bmj.d8279. No abstract available.
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Other Identifiers
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M2020 UK01
Identifier Type: -
Identifier Source: org_study_id
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