A Prospective Validation Study of a Rapid Point-of-Care Breath Test for Breast Cancer
Completed
Conditions studied: Breast Cancer
In brief
This is a multicenter, blinded prospective study of 2,000 women undergoing mammography for breast -related symptoms or signs. Breath tests will be performed in order to demonstrate that the outcome of mammography results combined with breast test results improves clinical sensitivity and specificity in a group that has an increased prior probability of cancer. Breath will be collected and analyzed with a rapid point-of-care instrument (BreathLink™) and also with a laboratory-based assay of samples collected into an inflatable bag (BreathBag™).
Key facts
- Study ID
- NCT02888366
- Run by
- Menssana Research, Inc.
- People needed
- 500
- Starts
- 2017-03-01
- Expected to finish
- 2018-08-30
- Last updated by the study team
- 2018-10-29
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female aged 18 years or over
- Referred for mammography for a breast-related concern (e.g. breast mass, nipple discharge etc.)
- Understands the study, and is willing to give written informed consent to participate
- Approves collection of relevant additional data for clinical research record if and when it becomes available, including results of mammogram and any other imaging studies, biopsy results, TNM staging, and other relevant biomarker data e.g. status of BRCA1, BRCA2, HER2 and receptors (ER+ or ER-) and progesterone (PgR+ or PgR-)
You may not qualify if…
- Known serious or potentially life-threatening disease (e.g. severe cardiac or infectious disease)
- Previous history of treated breast cancer, or cancer of any other site, with the exception of basal cell carcinoma of skin.
Where it is running
- University of Southern California — Los Angeles, California, United States
- Hackensack Medical Center, Mountainside Hospital — Montclair, New Jersey, United States
- St. Michael's Medical Center — Newark, New Jersey, United States
- MD Anderson Cancer Center — Houston, Texas, United States
Full record on ClinicalTrials.gov
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