Early-Stage Breast CarcinomaPhase 1/2NCT02511301
Circadian Thermal Sensing to Detect Breast Disease
A Phase 1/2 study testing Cyrcadia CBR™ device placement for abnormality screening in people with Early-Stage Breast Carcinoma, run by Cyrcadia Health at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Early-Stage Breast Carcinoma
- What is being tested?
- Cyrcadia CBR™ device placement for abnormality screening
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 173 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2015to Feb 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 1 recruiting
- Active, not recruiting
The Ohio State University, Stephanie Spielman Comprehensive Cancer Center
Columbus, Ohio, 43212
- Recruiting
El Camino Hospital
Mountain View, California, 94040-4378
Kara Amber, B.S., CCRP, 650-962-4562, kara_amber@elcaminohospital.com
About this study
Official title: Circadian Thermal Sensing for the Detection of Breast Disease as a Supplemental Cancer Screening System
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.
Read the 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.
- Conditions
- Early-Stage Breast Carcinoma
- Being tested
- Cyrcadia CBR™ device placement for abnormality screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyrcadia CBR™ device placement for abnormality screeningDevice
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 group | Role | What they receive |
|---|---|---|
| Cyrcadia CBR™ Device | Experimental | 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 Receives: Device: Cyrcadia CBR™ device placement for abnormality screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive Analytic Analysis (PAA) Sensitivity and Specificity
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.
Measured: 7 to 30 days after CBR placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early-Stage Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 173 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyrcadia Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stanford University, Salesforce, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Joshua Ellenhorn, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511301
- Sponsor's protocol ID
- CH001
- Status last verified
- Dec 2018
- First submitted
- 18 Jun 2015
- Last updated
- 3 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian Thermal Sensing for the Detection of Breast Disease as a Supplemental Cancer Screening System
- ClinicalTrials.gov ID
- NCT02511301
- Acronym / sponsor ID
- CH001
- Conditions
- Early-Stage Breast Carcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 173 participants (estimated)
- Lead sponsor
- Cyrcadia HealthIndustry (pharma, biotech, devices)
- Collaborators
- Stanford University, Salesforce, Ohio State University
- Study start
- Jun 2015
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cyrcadia CBR™ Device | Experimental | Device: Cyrcadia CBR™ device placement for abnormality screeningCyrcadia 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 |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cyrcadia CBR™ device placement for abnormality screeningCyrcadia 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 |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Ellenhorn, MD principal investigator
Cedars-Sinai Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cyrcadia CBR™ device placement for abnormality screening in people with Early-Stage Breast Carcinoma, run by Cyrcadia Health at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Norell, B.A., CCRA (775-233-1211, manorell@cyrcadiahealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive Analytic Analysis (PAA) Sensitivity and Specificity (time frame: 7 to 30 days after CBR placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2019.