Clinical trial NCT04755829: Breath Test to Predict Breast Cancer and Outcome of Mammography
Official title: Breath Test to Predict Breast Cancer and Outcome of Mammography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Abnormal Mammogram, Unspecified
Keywords: screening mammography
biomarker of breast disease
Lead sponsor: Menssana Research, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Mount Vernon Cancer Centre
name: Zuyderland Medical Centre
name: University of Erlangen-Nürnberg
First posted: 2021-02-16
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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)

Brief summary: 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.

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. -

Primary outcomes:
measure: BREATH TEST TO PREDICT BREAST CANCER
timeFrame: 2 years
measure: BREATH TEST TO PREDICT OUTCOME OF MAMMOGRAPHY
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Erlangen
country: Germany
facility: University of Erlangen
city: Heerlen
country: Netherlands
facility: Zuyderland Medical Center
city: Middlesex
country: United Kingdom
facility: Frimley Health NHS Foundation Trust
Study officials:
affiliation: Frimley Health NHS Foundation Trust
name: Alexandra Tenovici
role: PRINCIPAL_INVESTIGATOR
affiliation: Zuyderland Medical Center
name: Marc Lobbes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Erlangen-Nürnberg
name: Peter Fasching, MD
role: PRINCIPAL_INVESTIGATOR
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