Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
NCT ID: NCT02078570
Last Updated: 2016-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Breast Cancer ACR BI-RAD Category 3 or 4 result
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
* Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment
* Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
* Samples collected under IRB approval and Informed Consent
* Testing performed under IRB approval or waiver (as applicable)
* Previous approved procedures to enroll patients: breast augmentation \& cyst aspiration
Exclusion Criteria
* Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
* Subjects that have had a breast biopsy performed during the 6 months prior to the study visit
* Samples not collected under IRB approval and Informed Consent
* Testing not performed under IRB approval or waiver (as applicable)
* Prior breast cancer diagnosis.
25 Years
75 Years
FEMALE
No
Sponsors
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Provista Diagnostics, Inc
INDUSTRY
Responsible Party
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Locations
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St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
Sutter Institute
Sacramento, California, United States
Scripps
San Diego, California, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sinai Grace
Detroit, Michigan, United States
Mayo Clinic - Rochester
Rochester, Minnesota, United States
Summit Medical Group Breast Center New Jersey
Berkeley Heights, New Jersey, United States
Cleveland Clinic
Cleveland, Ohio, United States
Mercy Womens Center
Oklahoma City, Oklahoma, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
Countries
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Related Links
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Related Info
Other Identifiers
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dtectDx-Breast-002
Identifier Type: -
Identifier Source: org_study_id