A Prospective Longitudinal Breast Cancer Study



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:2/17/2019
Start Date:May 2014
End Date:May 2020

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A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer

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 with any stage of breast cancer.

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 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.

Inclusion Criteria:

- 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 Criteria:

- 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
We found this trial at
3
sites
Wilmington, North Carolina 28401
Principal Investigator: Kenneth Kotz, MD
Phone: 910-343-4044
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Wilmington, NC
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Boca Raton, Florida 33486
Phone: 561-955-6400
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Boca Raton, FL
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1600 S Andrews Ave
Fort Lauderdale, Florida 33316
(954) 355-4400
Principal Investigator: Archana Maini, MD
Phone: 954-712-3949
Broward Health Medical Center Broward Health, providing service for more than 75 years, is a...
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Fort Lauderdale, FL
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