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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COMPLETED
130 participants
OBSERVATIONAL
2014-05-31
2021-06-30
Brief Summary
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Detailed Description
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1. Obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease.
2. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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CA 15-3 Assay
Physicians use the CA 15-3 test result to manage their patients
Eligibility Criteria
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Inclusion Criteria
* Histologic/pathologic confirmation of breast cancer
* Any stage of disease: Newly diagnosed, stable, disease progression, surveillance
* Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring.
* Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible.
* Able to understand and willing to provide informed consent
Exclusion Criteria
* No histologic/pathologic confirmation of breast cancer
* Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer.
* Treatment plan with fewer than three visits expected in 3 years' time
* Unable to provide informed consent
18 Years
ALL
No
Sponsors
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Fujirebio Diagnostics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Diana Dickson
Role: STUDY_DIRECTOR
Fujirebio Diagnostics, Inc.
Locations
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Jane Skelton, MD
Boca Raton, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
New Hanover Regional Medical Center
Wilmington, North Carolina, United States
Countries
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Other Identifiers
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FDI-69
Identifier Type: -
Identifier Source: org_study_id
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