A Prospective Longitudinal Breast Cancer Study
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|ClinicalTrials.gov Identifier: NCT02270931|
Recruitment Status : Active, not recruiting
First Posted : October 22, 2014
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment|
|Breast Cancer||Device: CA 15-3 Assay|
The study objectives are described below:
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||130 participants|
|Official Title:||A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||May 2020|
|Estimated Study Completion Date :||May 2020|
- Device: CA 15-3 Assay
Physicians use the CA 15-3 test result to manage their patients
- Measure CA 15-3 in Breast Cancer Patients [ Time Frame: 3 years ]130 patients with Recurrence or Progressive Breast Cancer.
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02270931
|United States, Florida|
|Jane Skelton, MD|
|Boca Raton, Florida, United States, 33486|
|Broward Health Medical Center|
|Fort Lauderdale, Florida, United States, 33316|
|United States, North Carolina|
|New Hanover Regional Medical Center|
|Wilmington, North Carolina, United States, 28402|
|Study Director:||Diana Dickson||Fujirebio Diagnostics, Inc.|