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Circadian Thermal Sensing to Detect Breast Disease

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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

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.

Condition or disease Intervention/treatment Phase
Early-Stage Breast Carcinoma Device: Cyrcadia CBR™ device placement for abnormality screening Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 173 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Circadian Thermal Sensing for the Detection of Breast Disease as a Supplemental Cancer Screening System
Study Start Date : June 2015
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
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
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02511301


Contacts
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Contact: Marie Norell, B.A., CCRA 775-233-1211 manorell@cyrcadiahealth.com

Locations
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United States, California
El Camino Hospital Recruiting
Mountain View, California, United States, 94040-4378
Contact: Kara Amber, B.S., CCRP    650-962-4562    kara_amber@elcaminohospital.com   
United States, Ohio
The Ohio State University, Stephanie Spielman Comprehensive Cancer Center Active, not recruiting
Columbus, Ohio, United States, 43212
Sponsors and Collaborators
Cyrcadia Health
Stanford University
Salesforce
Ohio State University
Investigators
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Principal Investigator: Joshua Ellenhorn, MD Cedars-Sinai Medical Center

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Responsible Party: Cyrcadia Health
ClinicalTrials.gov Identifier: NCT02511301     History of Changes
Other Study ID Numbers: CH001
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: January 3, 2019
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Breast Diseases
Neoplasms by Site
Neoplasms
Skin Diseases