Status:
UNKNOWN
Breath Test to Predict Breast Cancer and Outcome of Mammography
Lead Sponsor:
Menssana Research, Inc.
Collaborating Sponsors:
Mount Vernon Cancer Centre
Zuyderland Medical Centre
Conditions:
Breast Cancer
Abnormal Mammogram, Unspecified
Eligibility:
FEMALE
18+ years
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-clea...
Eligibility Criteria
Inclusion
- Group 1: Normal screening mammogram
- Female aged 18 years or older
- Understands the study, and is willing to give written informed consent to participate
- If a screening mammogram was performed during the preceding six month period, then the results were reported as normal (BIRADS 1 or 2)
- 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\*.
- 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
- Previous history of an abnormal mammogram, breast disease, or breast biopsy
- Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
- Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
- Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
- General anesthesia during the 10-day period prior to breath collection.
- Group 2: Abnormal screening mammogram
- Inclusion Criteria:
- Female aged 18 years or older
- Understands the study, and is willing to give written informed consent to participate
- Abnormal screening mammogram during preceding six months (BIRADS 3-6)
- 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:
- Previous history of cancer of any site, with the exception of basal cell carcinoma of skin
- Previous history of breast biopsy
- Concurrent serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
- Concurrent acute pulmonary disease (e.g. influenza, influenza-like illness, acute asthma, or pneumonitis).
- General anesthesia during the 10-day period prior to breath collection. -
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04755829
Start Date
March 1 2021
End Date
March 1 2023
Last Update
February 16 2021
Active Locations (3)
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1
University of Erlangen
Erlangen, Germany
2
Zuyderland Medical Center
Heerlen, Netherlands
3
Frimley Health NHS Foundation Trust
Middlesex, United Kingdom, HA6 2RN