NON-INVASIVE CONFIRMATORY DETECTION OF BREAST CANCER (NICE-BC)

  • STATUS
    Recruiting
  • sponsor
    OncoCyte Corporation
Updated on 25 March 2021

Summary

NON-INVASIVE CONFIRMATORY DETECTION OF BREAST CANCER (NICE-BC)

Description

The purpose of this research study is to develop a blood test for the detection of breast cancer. You are being asked to be in this study because you have had a breast evaluation (such as a mammogram, ultrasound or MRI (magnetic resonance imaging). Experimental tests, such as those used on the blood collected in this research study, are also known as “investigational.” This means the tests have not been approved by the U.S. Food and Drug Administration (FDA). In this research study, the accuracy of these blood tests will be determined by comparing the results with other tests as determined by your study doctor.

This is not a treatment study. You should not expect to receive any direct medical benefits from your participation in this study. No individual results will be returned to you or to your doctor, and no decisions will be made about any further treatment based only on the results of the results of the research done on your blood sample in this study. If you are interested in the study’s outcome, you can request the Sponsor to provide you with a copy of the study’s overall results when it is completed. The information from this research study may lead to improvements in the diagnosis and treatment of women with breast cancer.

Details
Condition Breast Cancer
Clinical Study IdentifierTX149304
SponsorOncoCyte Corporation
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Women age 18 years or older
Willing and able to tolerate venipuncture for removal of up to 30 mL of blood
BI-RADS Assessment category 3 or 4 (radiology) as determined by your physician

Exclusion Criteria

Under 18 years old
Inadequate screening or diagnostic imaging
Pregnant or nursing
A history of any other primary malignancy, with the exception of non-melanoma skin cancer
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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