Status:
COMPLETED
A Prospective Longitudinal Breast Cancer Study
Lead Sponsor:
Fujirebio Diagnostics, Inc.
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed wi...
Detailed Description
The study objectives are described below: 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 u...
Eligibility Criteria
Inclusion
- Males and females, age≥ 18 years
- 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
- Males and females, age \<18 years
- 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
Key Trial Info
Start Date :
May 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT02270931
Start Date
May 1 2014
End Date
June 30 2021
Last Update
August 17 2021
Active Locations (3)
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1
Jane Skelton, MD
Boca Raton, Florida, United States, 33486
2
Broward Health Medical Center
Fort Lauderdale, Florida, United States, 33316
3
New Hanover Regional Medical Center
Wilmington, North Carolina, United States, 28402