Early-Stage Breast Carcinoma
Conditions
Brief summary
The purpose of this study is to determine if Cyrcadia's Circadian Biometric Recorder (CBR™), which is attached to soft biometric patches worn on the body, can improve early breast cancer detection along with mammography or as a stand alone device.
Detailed description
The Cyrcadia CBR™ (Circadian Biometric Recorder) includes wearable biometric patches and a detachable data recording device. The CBR™ records chronobiologic data while the patient is totally ambulatory and going about her normal daily routine. Following removal of the detachable data recording device from the wearable biometric patches, the data is transferred to a computer for analysis. The Cyrcadia CBR™ will be placed on the patient for the duration of 2 to 24 hours. There is no restriction of daily activity. The study subject is requested to sponge bathe rather than shower while wearing the device, keeping the device dry during the testing procedure. After this period, the CBR™ will be removed and the data will be transferred to a computer for analysis. The primary endpoint of this 173 patient study is to determine the accuracy of Cyrcadia CBR™ as a supplemental screening device to mammography and ultrasound in predicting a diagnosis of breast cancer. Specific emphasis will be on the utilization of the CBR as a secondary screening device to reduce the number of biopsies currently performed on non-cancerous tissue. A secondary emphasis will be on the CBR to act as an improved screening solution over mammography specifically in those patients with dense breast parenchymal tissue. Other endpoints of the study are: * to determine the accuracy of Cyrcadia CBR™, including the positive predictive value, negative predictive value, false negative rate and false positive rate. * to determine the optimal wear time for the Cyrcadia CBR™. * to demonstrate substantial equivalent or improved results when applied to Cyrcadia original patient case study with identical advanced neural network analysis computational results. Study subjects will be followed at 6, 12, 18, and 24 months to update their clinical status.
Interventions
DEVICECyrcadia CBR™ device placement for abnormality screening
Cyrcadia CBR™ device, including adhesive patches on both breasts connected to a small recorder, is placed on the study subject for 2 to 24 hours. After the test period, the CBR™ will be removed and the data will be downloaded to a central site for analysis. There are no interventions after the CBR™ is removed from the Study Subject.
Sponsors
Stanford University
Salesforce
Ohio State University
Cyrcadia Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with a BI-RADS category 4 or 5 designation on mammogram * Women with a BI-RADS category 4 or 5 designation on breast ultrasound * Women with a BI-RADS category 4 or 5 designation on breast MRI * Women who are willing to undergo a complete evaluation and/or biopsy procedure if recommended by the treating physician
Exclusion criteria
* Less than 21 years of age * Unable to sign the consent form * Pregnant or lactating * Physically unable to wear the Cyrcadia CBR™ for 6 hours * Previous mastectomy * Any breast surgery or biopsy within the last 90 days * Any trauma to the breast within the last 90 days * Any biopsy or treatment for the BI-RADS category 4 or 5 abnormality * Refusal to undergo recommended diagnostic evaluation of the BI-RADS category 4 or 5 abnormality
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive Analytic Analysis (PAA) Sensitivity and Specificity | 7 to 30 days after CBR placement | The data is analyzed using a predefined set of algorithms, referred to as Predictive Analytic Analysis (PAA) Outcome is measured by: NUMBER OF PATIENTS WHOSE INVESTIGATIVE CBR DEVISE RESULTS MATCH OF THOSE OF THE BIOPSY RESULTS. |
Countries
United States
Contacts
Primary ContactMarie Norell, B.A., CCRA
Outcome results
None listed