Breath Test to Predict Breast Cancer and Outcome of Mammography

• Conditions: Breast Cancer; Abnormal Mammogram, Unspecified
• Interventions: Device: BreathX test for breath VOCs

• Registration Number: NCT04755829
• Lead Sponsor: Menssana Research, Inc.

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.

Study Timeline

• Status Verified: 2021-02
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-02-12
• Last Update Submitted: 2021-02-12
• Study First Posted: 2021-02-16
• Last Update Posted: 2021-02-16
• Study Start: 2021-03
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

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. -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	BreathX test for breath VOCs	Abnormal screening mammogram (BIRADS 3 to 6)
Group 1	BreathX test for breath VOCs	Normal screening mammogram (BIRADS 1 or 2)

Primary Outcome Measures

Name	Time	Method
BREATH TEST TO PREDICT OUTCOME OF MAMMOGRAPHY	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
BREATH TEST TO PREDICT BREAST CANCER	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.

Trial Locations

Locations (3)

Zuyderland Medical Center; 🇳🇱 Heerlen, Netherlands

Frimley Health NHS Foundation Trust; 🇬🇧 Middlesex, United Kingdom

University of Erlangen; 🇩🇪 Erlangen, Germany