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Circadian Thermal Sensing to Detect Breast Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02511301
Recruitment Status : Recruiting
First Posted : July 30, 2015
Last Update Posted : January 3, 2019
Sponsor:
Collaborators:
Stanford University
Salesforce
Ohio State University
Information provided by (Responsible Party):
Cyrcadia Health

Tracking Information
First Submitted Date  ICMJE June 18, 2015
First Posted Date  ICMJE July 30, 2015
Last Update Posted Date January 3, 2019
Study Start Date  ICMJE June 2015
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2015)
Predictive Analytic Analysis (PAA) Sensitivity and Specificity [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Circadian Thermal Sensing to Detect Breast Disease
Official Title  ICMJE Circadian Thermal Sensing for the Detection of Breast Disease as a Supplemental Cancer Screening System
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Early-Stage Breast Carcinoma
Intervention  ICMJE Device: Cyrcadia 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.
Study Arms  ICMJE Experimental: Cyrcadia CBR™ Device
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
Intervention: Device: Cyrcadia CBR™ device placement for abnormality screening
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 28, 2015)
173
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Marie Norell, B.A., CCRA 775-233-1211 manorell@cyrcadiahealth.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02511301
Other Study ID Numbers  ICMJE CH001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cyrcadia Health
Study Sponsor  ICMJE Cyrcadia Health
Collaborators  ICMJE
  • Stanford University
  • Salesforce
  • Ohio State University
Investigators  ICMJE
Principal Investigator: Joshua Ellenhorn, MD Cedars-Sinai Medical Center
PRS Account Cyrcadia Health
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP